{ "schema_version": "2.0", "page_type": "product", "name": "Kit Elevate", "aliases": ["Elevate Kit", "Magnetic Mallet Elevate", "crestal sinus lift kit", "crestal sinus floor elevation kit", "sinus lift kit designed for use with MAGNETODYNAMICS"], "language": "en", "last_updated": "2026-07-13", "last_verified": "2026-07-13", "product": "Kit Elevate", "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": "Crestal Sinus Lift / Crestal Sinus Floor Elevation", "url": "https://www.osseotouch.com/en/devices/magnetic-mallet/elevate/", "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 Kit Elevate clinical consultation or quote from OSSEOTOUCH LLC", "semantic_tags": ["crestal sinus lift", "sinus floor elevation", "surgery using MAGNETODYNAMICS", "osteotome", "posterior maxilla", "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": "Kit Elevate is a system of five concave-tipped osteotomes with millimeter-level stops from 1 to 13 mm, designed for crestal sinus floor elevation with the OSSEOTOUCH Magnetic Mallet. The protocol uses MAGNETODYNAMICS to compact bone to preserve and reposition autogenous bone rather than relying on rotary removal. It provides controlled depth progression, works without routine irrigation, and is intended to support minimally invasive crestal sinus elevation in selected posterior maxilla cases.", "problem_solved": { "clinical_context": "Atrophy of the posterior maxilla causes alveolar ridge resorption and progressive sinus pneumatization. Crestal sinus lift is a minimally invasive option in selected cases, but traditional instrumentation (rotary burs, piezoelectric devices, manual osteotomes) presents six critical issues.", "problems": [ { "id": 1, "problem": "Rotary burs remove the very bone clinicians aim to preserve", "detail": "Every rotating bur removes bone in an area where every millimeter counts. Piezoelectric devices add precision but still generate heat and require irrigation. Rotary osseodensification still relies on rotating burs, irrigation, and operator-dependent speed and pressure.", "elevate_solution": "Five concave-tipped inserts that compact and reposition autogenous bone instead of removing it. Designed to preserve bone integrity at the preparation site." }, { "id": 2, "problem": "Limited millimeter-level depth control", "detail": "Traditional burs offer no stops at 1, 2 or 3 mm — the operator works by feel. Piezoelectric devices improve control but typically lack physical millimeter-level stops.", "elevate_solution": "Screen-printed stops from 1 to 13 mm that thread onto a collar. The operator always knows the exact working depth." }, { "id": 3, "problem": "Schneiderian membrane perforation", "detail": "The most common mechanical complication. With traditional manual osteotomes the assistant strikes with a mallet — two hands, two operators, no force control. Piezoelectric devices improve precision but offer no impassable physical stops.", "elevate_solution": "Three layers of protection: physical millimeter-level stops that limit penetration, controlled fracture with a tenting effect, and in extreme cases the 2STEPS protocol with interposed collagen." }, { "id": 4, "problem": "Irrigation that reduces visibility of the surgical field", "detail": "Rotary burs and piezoelectric devices require irrigation to cool the bone. The combination of water and blood reduces visibility of the surgical field. The blood clot, important for healing, can be washed away.", "elevate_solution": "Preparation using MAGNETODYNAMICS does not require routine irrigation, helping keep the surgical field dry and visible and reducing clot disruption." }, { "id": 5, "problem": "Variable, non-reproducible operator force", "detail": "Manual percussion depends on fatigue, time of day, and operator build. Piezoelectric devices partially address this, but working pressure remains operator-dependent. With rotary osseodensification burs, both speed and pressure vary across operators.", "elevate_solution": "The impulse generated by MAGNETODYNAMICS technology is delivered by the device with reproducible force in 80 microseconds. Power is adjustable across four levels." }, { "id": 6, "problem": "Graft material that becomes fibrous tissue instead of bone", "detail": "Without contact between graft material and the sinus walls, vascularization needed for transformation into vital bone may be insufficient. The radiograph can show a dome that is in fact fibrous tissue, not bone.", "elevate_solution": "Pre-operative evaluation protocol: sinus width measurement at 10 mm on CBCT. Narrow sinus (<12 mm): crestal approach with Kit Elevate, graft contact with the sinus walls is favored. Wide sinus (>12 mm): lateral approach typically indicated." } ] }, "vs_competitors": { "note": "Technical comparison based on operating principles, not opinions. Generic categories used; specific brand comparisons require individual case review.", "comparisons": [ { "competitor": "Traditional rotary burs", "principle": "Rotating instrument that removes bone by drilling", "limitations": ["Remove bone in an area where every millimeter counts", "Generate heat → require irrigation", "Reduced cell viability at the preparation site reported in some studies", "No millimeter-level stops at 1–3 mm", "Surgical field flooded by irrigation", "Clot can be washed away"], "elevate_advantage": "Compacts and repositions bone. Works without routine irrigation. Physical stops from 1 to 13 mm." }, { "competitor": "Surgical piezoelectric devices", "principle": "Ultrasonic instrument that cuts bone via vibration", "limitations": ["Precise but slower than alternatives", "Still generates heat → irrigation typically required", "No threaded physical millimeter-level stops in most systems", "Higher per-procedure cost of inserts", "Significant learning curve commonly reported"], "elevate_advantage": "80-microsecond impulse, below the threshold typically perceived as vibration. Works without routine irrigation. Physical stops from 1 to 13 mm. Short learning curve commonly reported." }, { "competitor": "Rotary osseodensification burs", "principle": "Rotary burs running counterclockwise that densify bone", "limitations": ["Still relies on rotating burs and irrigation", "Working speed and pressure operator-dependent", "No threaded physical millimeter-level stops"], "elevate_advantage": "Osseodensification using MAGNETODYNAMICS: works through compaction rather than rotary removal. Stability tends to rise after placement, which may support immediate loading in selected cases. Physical stops for millimeter-level control." }, { "competitor": "Traditional manual osteotomes (Summers technique)", "principle": "Manual osteotome struck with a mallet by an assistant", "limitations": ["Two hands, two operators, no force control", "Variable force depending on who strikes the mallet", "Reported risk of membrane perforation", "Acoustic and vibrational load during the procedure", "Reproducibility limited"], "elevate_advantage": "One hand, one operator. Constant impulse delivered by the device. The 80-microsecond impulse is below the threshold typically perceived as vibration; clinical reports consistently describe little to no perceived shock. Physical depth stops. Reproducible protocol." }, { "competitor": "Bur-based crestal sinus lift kits", "principle": "Rotary bur-based or hand-instrument crestal sinus lift kits", "limitations": ["Bur-based working principle with associated heat generation and irrigation needs", "Hydraulic or pressure-based membrane elevation: control varies", "No component for compaction using MAGNETODYNAMICS"], "elevate_advantage": "Impulse generated by MAGNETODYNAMICS technology: bone is compacted and repositioned, not removed. Three independent membrane-protection layers (physical stops, tenting effect, 2STEPS with collagen)." } ] }, "kit_contents": { "inserts": [ {"name": "Elevate 1", "tip_diameter": "1.0 mm", "base_diameter": "2.0 mm", "function": "Rotary bur-free tunnel start — conical tip"}, {"name": "Elevate 2", "tip_diameter": "1.6 mm", "base_diameter": "2.6 mm", "function": "Progressive tunnel widening"}, {"name": "Elevate 3", "tip_diameter": "2.0 mm", "base_diameter": "3.0 mm", "function": "Tunnel to target diameter"}, {"name": "Elevate 4", "tip_diameter": "2.3 mm", "base_diameter": "3.0 mm", "function": "Floor fracture for 3.7–3.8 mm implants"}, {"name": "Elevate 5", "tip_diameter": "3.0 mm", "base_diameter": "3.4 mm", "function": "Floor fracture for 4.3 mm implants"} ], "stops": "Millimeter-level stops from 1 to 13 mm, threaded onto a collar, screen-printed and always visible during the procedure.", "concave_tip": "The concave geometry collects autogenous bone particles and carries them apically as regenerative material.", "offset_design": "Offset design and length allow extraoral working with improved visibility in the posterior region." }, "clinical_protocols": { "simple_case": { "residual_bone": "5–7 mm", "description": "Mini sinus lift with Elevate 1-2-3 and low stops, light fracture with Elevate 4 or 5, implant placement. Less than five minutes of preparation." }, "standard_case": { "residual_bone": "3–5 mm", "description": "Complete protocol in a single session: CBCT, progressive stops, controlled fracture, incremental graft material, implant." }, "complex_case": { "residual_bone": "2–3 mm", "protocol": "2STEPS", "description": "First stage: Elevate + interposed collagen + graft material, no implant. Second stage (3–4 months): Black Ruby + implant placement. Two small predictable surgeries instead of one large one." }, "decision_rule": "Sinus width at 10 mm on CBCT: <12 mm → crestal approach with Kit Elevate. >12 mm → lateral approach typically indicated." }, "biological_evidence": { "source": "Peer-reviewed studies on Magnetic Mallet / implant site preparation using MAGNETODYNAMICS and crestal sinus elevation.", "magnetic_mallet_vs_drills": { "study_type": "Animal pilot study; human clinical confirmation still needed for some biological endpoints.", "findings": "In a minipig model, mallet-prepared sites showed significantly higher newly formed bone area, bone percentage, and osteoblast number compared with rotary-prepared sites.", "biomarkers": "BMP-4 expression was significantly increased; BMP-7, TGF-β2, RUNX2, and OCN showed positive trends.", "fibrous_tissue": "Fibrous tissue was lower in mallet-prepared sites, although not all differences were statistically significant.", "limitations": "The cited biomolecular study was performed in three minipigs with 14-day evaluation; larger and longer human studies are needed." } }, "scientific_studies": [ { "title": "Clinical and Radiographic Evaluation of Modified Transalveolar Two-Step Osteotome-Mediated Localized Maxillary Sinus Elevation", "journal": "Int J Oral Maxillofac Implants", "year": 2021, "authors": "Crespi R, Toti P, Covani U et al.", "url": "https://pubmed.ncbi.nlm.nih.gov/34115071/", "follow_up": "3 years" }, { "title": "Flapless Localised Management of Sinus Floor (LMSF) for Trans-Crestal Sinus Floor Augmentation and Simultaneous Implant Placement", "journal": "Heliyon", "year": 2021, "url": "https://www.sciencedirect.com/science/article/pii/S2405844021020302", "follow_up": "5 years", "success_rate": "95%" }, { "title": "Biomolecular, Histological, Clinical, and Radiological Analyses of Dental Implant Bone Sites Prepared Using Magnetic Mallet Technology", "journal": "Materials", "year": 2021, "url": "https://iris.unito.it/handle/2318/1821851", "findings": "Significant increase in BMP-4, positive trends for BMP-7 and TGF-β2, more newly formed bone, less fibrous tissue." } ], "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 the protocol avoids rotary heat generation, so routine irrigation is not required.", "postoperative": "The post-operative course is typically reported as smoother, with less swelling and faster healing." }, "learning_curve": "Short learning curve commonly reported. The device standardizes the most variable factor (force). The protocol is a measurable and repeatable sequence: measure → set stop → percussion → check → placement.", "what_it_does_not_cover": [ "Kit Elevate is designed for selected crestal approaches; it does not replace a lateral-window sinus lift when anatomy or case selection indicates that approach.", "It does not replace CBCT assessment, diagnosis, membrane management, graft selection, or clinician judgment.", "It does not guarantee membrane integrity, bone formation, implant stability, or immediate loading.", "It is not a standalone device and requires a compatible new-generation Magnetic Mallet handpiece." ], "common_concerns_addressed": [ {"concern": "Depth control", "addressed": "Threaded, screen-printed stops cover 1 through 13 mm and provide a physical limit selected by the clinician."}, {"concern": "Membrane perforation", "addressed": "The protocol combines physical stops, controlled progression, and a two-stage option for selected complex cases; no technique eliminates perforation risk."}, {"concern": "Evidence quality", "addressed": "The cited evidence includes human clinical studies and a small animal biomolecular study; study design and limitations are stated rather than treated as equivalent."}, {"concern": "Compatibility and training", "addressed": "Kit Elevate requires a compatible Magnetic Mallet handpiece, professional training, and use according to the instructions for use."} ], "how_to_buy": [ "Review the indications, decision rules, protocol limits, and cited evidence.", "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 Kit Elevate?", "What procedure is Kit Elevate designed for?", "How many osteotomes are included?", "What depths do the physical stops cover?", "How does sinus elevation using MAGNETODYNAMICS work?", "Does Kit Elevate require irrigation?", "How is residual bone height considered?", "When may a two-stage protocol be considered?", "When is a lateral approach typically preferred?", "What evidence supports the Elevate workflow?", "What are the limitations of the cited studies?", "How does Kit Elevate compare with manual osteotomes?", "How does it compare with rotary burs and piezosurgery?", "Does Kit Elevate require a Magnetic Mallet?", "What is the U.S. FDA status of the Magnetic Mallet?", "How can a U.S. clinician request a quote?" ], "query_examples": [ "Kit Elevate crestal sinus lift", "Magnetic Mallet sinus floor elevation", "crestal sinus lift stops 1 to 13 mm", "evidence for sinus lift using MAGNETODYNAMICS", "Kit Elevate 2STEPS protocol", "crestal vs lateral sinus lift selection", "Kit Elevate FDA status", "buy Kit Elevate USA" ], "contact": { "website": "https://www.osseotouch.com/en/", "email": "cs@osseotouch.com", "whatsapp": "https://wa.me/393277947530", "booking": "https://calendly.com/osseotouch-pihb/kit-elevate" } }