{ "schema_version": "2.0", "page_type": "product", "name": "BLEXO", "aliases": ["BLEXO extraction kit", "BLEXO extractors", "BLEXO Pathfinder", "BLEXO AngleFit", "Magnetic Mallet extraction kit", "atraumatic extraction kit"], "language": "en", "last_updated": "2026-07-13", "last_verified": "2026-07-13", "product": "BLEXO", "manufacturer": "Meta Ergonomica S.r.l.", "brand_owner_distributor": "OSNRGY SRL (brand OSSEOTOUCH)", "us_commercial_entity": "OSSEOTOUCH LLC — Fairhope, Alabama", "us_fda_agent": "Thema USA — New York, New York", "device": "Magnetic Mallet", "category": "Atraumatic Tooth Extraction Kit", "url": "https://www.osseotouch.com/en/devices/magnetic-mallet/blexo/", "inLanguage": "en", "target_market": "United States primary; international English-speaking markets (UK, Middle East, Asia-Pacific, Africa, Americas) via authorized distributors", "primary_cta": "Request a BLEXO consultation or quote from OSSEOTOUCH LLC", "semantic_tags": ["atraumatic extraction", "periotomy performed with MAGNETODYNAMICS", "socket preservation", "root tip extraction", "impacted third molar", "Magnetic Mallet"], "regulatory": { "eu": "Magnetic Mallet is a Class IIa medical device under EU MDR 2017/745; legal manufacturer: Meta Ergonomica S.r.l.; notified body: TÜV Rheinland.", "us": "Meta Ergonomica S.r.l. is registered and listed with the U.S. FDA under Establishment Registration 3011922183. Magnetic Mallet product code GEY maps to 21 CFR 878.4820, Class I and 510(k)-exempt, subject to general controls.", "us_agent": "Thema USA — New York, New York" }, "summary": "BLEXO is a system of eight extractors designed for use with MAGNETODYNAMICS on the OSSEOTOUCH Magnetic Mallet. It performs atraumatic tooth extraction through periotomy performed with MAGNETODYNAMICS: the impulse enters the periodontal ligament space with a progressive wedge effect, mobilizing the tooth without applying leverage forces on alveolar walls. Two complementary families — Pathfinder (four straight extractors) and AngleFit (four angled extractors) — cover root tip extraction, fractured apices, impacted third molars, and complex posterior cases.", "problem_solved": { "clinical_context": "Tooth extraction is among the most common procedures in dentistry, but traditional instrumentation (forceps, dental elevators, levers) can damage alveolar bone when leverage forces are applied to socket walls. In posterior sectors and complex cases (root tips, impacted third molars, multi-rooted molars), conventional instruments may compromise the socket required for socket preservation and immediate implant placement.", "problems": [ { "id": 1, "problem": "Traditional forceps fracture buccal cortical plates", "detail": "Forceps and elevators apply leverage on the alveolar walls. Buccal cortical plates fracture, root tips break, soft tissues are traumatized.", "blexo_solution": "Eight extractors designed for use with MAGNETODYNAMICS that enter the periodontal ligament space without leverage on bone. Buccal and lingual cortical plates remain intact." }, { "id": 2, "problem": "No millimeter-level access in narrow periodontal spaces", "detail": "Conventional instruments cannot enter the residual periodontal space of fractured apices, retained roots, or flat conical roots — leading to extensive osteotomies.", "blexo_solution": "BLEXO Micro (ultra-thin) and Slim (slim & elongated) profiles enter narrow PDL spaces without bone removal." }, { "id": 3, "problem": "Posterior molar surfaces unreachable with straight instruments", "detail": "Straight forceps cannot reach mesial and distal surfaces of molars in posterior sectors. Impacted third molars demand extensive osteotomies.", "blexo_solution": "AngleFit Mesial, Distal, RightSide, LeftSide — four angled extractors designed for posterior molar surfaces and impacted third molars." }, { "id": 4, "problem": "Operator-dependent force, fatigue, time-of-day variability", "detail": "Manual leverage with forceps depends on operator strength, fatigue, and case-specific feel. Reproducibility is limited.", "blexo_solution": "The impulse generated by MAGNETODYNAMICS technology is delivered by the device with reproducible force in 80 microseconds. Power level 1 throughout — no adjustment needed during the workflow." }, { "id": 5, "problem": "Compromised socket preservation", "detail": "Conventional extraction often destroys the alveolar walls that should be preserved, requiring grafting or delayed implant placement.", "blexo_solution": "The alveolus typically remains intact post-extraction, ready for immediate implant placement or natural healing without additional grafting." }, { "id": 6, "problem": "Risk of inferior alveolar nerve injury in third molar surgery", "detail": "Extensive osteotomy and uncontrolled leverage near impacted lower third molars increase the risk of nerve damage.", "blexo_solution": "AngleFit Mesial + Distal mobilize the third molar with osteotomy kept to a minimum, which can reduce the risk of inferior alveolar nerve injury." } ] }, "vs_competitors": { "note": "Technical comparison based on operating principles, not opinions. Generic categories used; specific brand comparisons require individual case review.", "comparisons": [ { "competitor": "Traditional dental forceps", "principle": "Manual gripping and rocking of the tooth to break the periodontal ligament", "limitations": ["Apply leverage forces on alveolar walls", "Fracture buccal cortical plates in posterior sectors", "Cannot reach narrow PDL spaces or fractured apices", "Operator-dependent force, fatigue-sensitive", "Reproducibility limited"], "blexo_advantage": "Periotomy performed with MAGNETODYNAMICS without leverage on bone. Eight dedicated profiles for every root morphology and access angle. Reproducible force delivered by the device." }, { "competitor": "Surgical elevators and levers", "principle": "Wedge effect and rotational leverage to mobilize the tooth", "limitations": ["Leverage forces on adjacent teeth and alveolar bone", "Risk of fracturing root tips during mobilization", "Requires significant operator skill"], "blexo_advantage": "Impulse generated by MAGNETODYNAMICS technology delivers the wedge effect without leverage. The instrument enters the PDL space, the tooth mobilizes from the inside out." }, { "competitor": "Periotomes (manual)", "principle": "Thin manual blade inserted in the periodontal space, struck or pushed by hand", "limitations": ["Operator-dependent force", "Slow on multi-rooted teeth", "Limited profile selection"], "blexo_advantage": "Periotomy performed with MAGNETODYNAMICS: the impulse provides the force, the surgeon controls the position. Eight dedicated profiles." }, { "competitor": "Piezoelectric extraction tips", "principle": "Ultrasonic vibration cuts the periodontal ligament", "limitations": ["Generates heat, requires irrigation", "Slower than alternatives in clinical comparisons", "Higher per-procedure cost of inserts"], "blexo_advantage": "80-microsecond impulse, no continuous vibration, no irrigation required. In a pilot split-mouth RCT (Bennardo 2023), mean operative time was 544.9s with Magnetic Mallet vs 682.3s with conventional instruments and 901.0s with piezosurgery." }, { "competitor": "Surgical extraction with rotary osteotomy", "principle": "Rotary burs to remove bone and access the root", "limitations": ["Removes bone in an area where every millimeter counts", "Generates heat → requires irrigation", "Compromises socket preservation"], "blexo_advantage": "BLEXO mobilizes the tooth without bone removal. The alveolus typically remains intact for socket preservation." } ] }, "kit_contents": { "instrument_families": { "pathfinder": { "label": "Pathfinder · four straight extractors", "description": "Four straight extractors with different profiles, designed to enter the periodontal space according to root morphology. They work through periotomy performed with MAGNETODYNAMICS: the Magnetic Mallet impulse pushes the instrument into the periodontal ligament space with a progressive wedge effect.", "instruments": [ { "name": "BLEXO Micro", "profile": "ultra-thin", "best_for": "Fractured apices, retained roots, narrow PDL spaces" }, { "name": "BLEXO Slim", "profile": "slim & elongated", "best_for": "Flat conical roots — incisors, premolars" }, { "name": "BLEXO Arc", "profile": "curved", "best_for": "Interproximal access, esthetic zone" }, { "name": "BLEXO LongRoot", "profile": "extended", "best_for": "Deep roots, palatally impacted canines (>20 mm)" } ] }, "anglefit": { "label": "AngleFit · four angled extractors", "description": "Four angled extractors designed to reach mesial, distal, and lateral surfaces of molars in posterior sectors. Each instrument has a specific angle for optimal access without interfering with adjacent teeth.", "instruments": [ { "name": "AngleFit Mesial", "profile": "mesial angle", "best_for": "Anterior molar surface, mesioangulated third molars" }, { "name": "AngleFit Distal", "profile": "distal angle", "best_for": "Posterior molar surface, retromolar access" }, { "name": "AngleFit RightSide", "profile": "right lateral", "best_for": "Right-side molars, buccal/lingual" }, { "name": "AngleFit LeftSide", "profile": "left lateral", "best_for": "Left-side molars, buccal/lingual (mirror)" } ] } }, "power_level": "Standard protocol commonly uses power level 1 for extraction workflows.", "working_principle": "Periotomy performed with MAGNETODYNAMICS: the 80-microsecond impulse pushes the extractor into the periodontal ligament space with a progressive wedge effect. The tooth mobilizes from the inside out, without leverage on alveolar walls." }, "clinical_scenarios": [ { "scenario": "Fractured apices and retained roots", "instruments": ["BLEXO Micro"], "description": "BLEXO Micro enters the residual periodontal space and mobilizes the fragment, often without the need for osteotomy or surgical flap." }, { "scenario": "Impacted third molars", "instruments": ["AngleFit Mesial", "AngleFit Distal"], "description": "AngleFit Mesial and Distal reach both surfaces of the third molar, keeping osteotomy to a minimum. Particularly indicated for mesioangulated lower third molars." }, { "scenario": "Multi-rooted molars", "instruments": ["AngleFit RightSide", "AngleFit LeftSide"], "description": "After crown separation, AngleFit RightSide and LeftSide engage each root individually, preserving alveolar bone for immediate implant placement." }, { "scenario": "Esthetic zone extractions", "instruments": ["BLEXO Arc"], "description": "BLEXO Arc follows the root convexity and enters interproximal spaces without contacting adjacent teeth — preserving soft tissue contours." }, { "scenario": "Deep roots and palatally impacted canines", "instruments": ["BLEXO LongRoot", "BLEXO Micro"], "description": "BLEXO LongRoot reaches deep root profiles (>20 mm); BLEXO Micro completes apex mobilization with minimal osteotomy." } ], "biological_evidence": { "source": "Peer-reviewed studies on Magnetic Mallet atraumatic tooth extraction.", "key_findings": { "operative_time": "Mean operative time: 544.9s with Magnetic Mallet, 682.3s with conventional instruments, 901.0s with piezosurgery (Bennardo 2023, pilot split-mouth RCT, 22 patients × 3 teeth).", "bone_resorption_molars": "Post-extraction bone resorption in molars: −22% with Magnetic Mallet vs −44% with conventional extraction (Menchini-Fabris 2022, controlled retrospective).", "post_op_comfort_and_healing": "No statistically significant differences in postoperative pain or 10-day wound healing were found among Magnetic Mallet, conventional instruments, and piezosurgery; no additional complications were reported. Magnetic Mallet required significantly less operative time (Bennardo 2023).", "systematic_review": "A systematic review including studies on tooth extraction reports favorable outcomes for the Magnetic Mallet in oral surgery and implantology (Bennardo 2022, Journal of Personalized Medicine).", "limitations": "Sample sizes range from 22-patient pilot RCTs to controlled retrospective cohorts; larger multicenter studies are ongoing." } }, "scientific_studies": [ { "title": "Comparison of MAGNETODYNAMICS, piezoelectric, and conventional dental extraction techniques: a split-mouth randomized controlled trial", "journal": "Dentistry Journal", "year": 2023, "authors": "Bennardo F, Barone S, Vocaturo C, Gheorghe DN, Cosentini G, Antonelli A, Giudice A.", "url": "https://www.mdpi.com/2304-6767/11/3/60", "design": "Pilot split-mouth RCT, 22 patients × 3 teeth" }, { "title": "Post-extraction bone resorption in molars: MAGNETODYNAMICS vs conventional extraction", "journal": "Journal of Clinical Medicine", "year": 2022, "authors": "Menchini-Fabris GB et al.", "url": "https://www.mdpi.com/2077-0383/11/4/922", "design": "Controlled retrospective study" }, { "title": "Usefulness of Magnetic Mallet in Oral Surgery and Implantology: A Systematic Review", "journal": "Journal of Personalized Medicine", "year": 2022, "authors": "Bennardo F, Barone S, Vocaturo C, Nucci L, Antonelli A, Giudice A.", "url": "https://pubmed.ncbi.nlm.nih.gov/35055423/", "doi": "10.3390/jpm12010108", "design": "Systematic review; includes 3 studies on tooth extraction" } ], "procedural_experience": { "vibration_threshold": "The 80-microsecond impulse generated by MAGNETODYNAMICS technology is below the threshold typically perceived as vibration.", "clinical_reports": "Clinical reports consistently describe little to no perceived shock during the procedure. There is no continuous rotary vibration, no rotary handpiece noise, and no irrigation required.", "postoperative": "No statistically significant differences in postoperative pain or 10-day wound healing have been reported among Magnetic Mallet, conventional instruments, and piezosurgery in pilot RCT data (Bennardo 2023)." }, "learning_curve": "Short learning curve commonly reported. The device standardizes the most variable factor (force). Eight dedicated profiles provide the appropriate instrument for each clinical scenario; the workflow is consistent across cases.", "what_it_does_not_cover": [ "BLEXO is an extraction instrument set; it does not replace diagnosis, imaging, flap design, sectioning, or clinician judgment.", "It does not guarantee socket preservation or eliminate every need for osteotomy, grafting, or delayed implant placement.", "It is not a standalone device and requires a compatible new-generation Magnetic Mallet handpiece.", "It is not intended for use by patients or unqualified operators." ], "common_concerns_addressed": [ {"concern": "Evidence for atraumatic extraction", "addressed": "The file identifies a 2023 pilot split-mouth RCT, a 2022 controlled retrospective study, and a 2022 systematic review, with study design and limitations stated."}, {"concern": "Posterior access", "addressed": "Four AngleFit instruments provide mesial, distal, right-side, and left-side access; four Pathfinder profiles address narrow or complex root morphology."}, {"concern": "Compatibility", "addressed": "BLEXO instruments require a compatible new-generation Magnetic Mallet handpiece and professional reprocessing according to the instructions for use."}, {"concern": "Clinical predictability", "addressed": "The device standardizes impulse delivery, but outcomes still depend on case selection, anatomy, and surgical technique."} ], "how_to_buy": [ "Review the clinical indications and evidence on this page.", "Contact OSSEOTOUCH LLC at cs@osseotouch.com or via the published WhatsApp channel for a clinical consultation.", "Confirm handpiece compatibility, training needs, availability, and the current written quote before purchase." ], "answers_questions": [ "What is BLEXO?", "What procedures is BLEXO designed for?", "How many instruments are included?", "What is the difference between Pathfinder and AngleFit?", "Can BLEXO be used for fractured root tips?", "Can BLEXO be used for impacted third molars?", "How does periotomy performed with MAGNETODYNAMICS work?", "Does BLEXO remove alveolar bone?", "What power level is commonly used?", "What evidence supports BLEXO extraction workflows?", "How does BLEXO compare with forceps and elevators?", "How does BLEXO compare with piezosurgery?", "Does BLEXO require a Magnetic Mallet?", "What is the U.S. FDA status of the Magnetic Mallet?", "How can a U.S. clinician request a quote?", "What does BLEXO not replace?" ], "query_examples": [ "BLEXO atraumatic extraction kit", "Magnetic Mallet root tip extraction", "BLEXO Pathfinder vs AngleFit", "atraumatic extraction socket preservation instruments", "BLEXO impacted third molar", "periotomy performed with MAGNETODYNAMICS evidence", "BLEXO FDA status", "buy BLEXO extraction kit USA" ], "contact": { "website": "https://www.osseotouch.com/en/", "email": "cs@osseotouch.com", "whatsapp": "https://wa.me/393277947530", "address": "Osseotouch LLC · 20585 County Road 13, Suite B, Fairhope, AL 36532" } }