{ "schema_version": "1.0", "page_type": "about_company", "name": "OSSEOTOUCH", "url": "https://www.osseotouch.com/en/about/", "language": "en", "inLanguage": "en", "target_market": "United States", "last_updated": "2026-05-02", "aliases": [ "OSSEOTOUCH", "OSSEOTOUCH commercial brand", "OSNRGY SRL brand", "Meta Ergonomica legal manufacturer", "Magnetic Mallet distributor", "About OSSEOTOUCH", "magnetodynamic surgical platform" ], "corporate_structure": { "commercial_brand": "OSSEOTOUCH", "brand_owner": "OSNRGY SRL", "legal_manufacturer": "Meta Ergonomica S.r.l.", "manufacturer_address": "Via Monte Nero 19, 20029 Turbigo (MI), Italy", "us_agent_for_fda": "Thema USA — 390 E 8th Street, 4A, New York, NY 10009", "us_commercial_team": "OSSEOTOUCH U.S. commercial team", "note": "OSSEOTOUCH is the commercial brand under which the Magnetic Mallet platform is distributed. The legal manufacturer (and the entity registered/listed with the U.S. FDA) is Meta Ergonomica S.r.l. (Italy). The brand owner is OSNRGY SRL." }, "summary": "OSSEOTOUCH is the commercial brand of OSNRGY SRL for the Magnetic Mallet platform, manufactured by Meta Ergonomica S.r.l. in Italy. The platform is a magnetodynamic surgical system for oral and implant surgery, available to clinicians worldwide for over 13 years and to U.S. clinicians for over a decade, according to company records. The handpiece generates a calibrated magnetic impulse that transfers controlled axial force to interchangeable surgical instruments — without rotary cutting and without rotary friction heat in the magnetodynamic phase. Bone is laterally displaced rather than removed (vital bone displacement). Meta Ergonomica S.r.l. is registered and listed with the U.S. FDA under Establishment Registration 3011922183 and product codes EIS · KDG · GEY (21 CFR 872.4565 / 878.4820). U.S. Agent: Thema USA, New York. ISO 13485:2016 (Certificate ICIM-13485-050738-00 / IQNET IT-149738). CE-marked under EU MDR. Active in 30+ countries on five continents.", "us_market_presence": { "tenure_years_worldwide": 13, "tenure_years_us": 10, "countries_active": "30+", "continents": 5, "statement": "The Magnetic Mallet platform has been available to U.S. clinicians for over a decade, according to company records. Used in implant surgery workflows including atraumatic extraction, sinus lift, split crest, implant site preparation, guided surgery, and crown removal." }, "regulatory": { "fda": { "registered_entity": "Meta Ergonomica S.r.l.", "establishment_registration": "3011922183", "registration_status": "Registered and listed (Title 21, 807 et seq.)", "product_codes": [ { "code": "EIS", "device": "Remover, Crown", "cfr": "21 CFR 872.4565" }, { "code": "KDG", "device": "Chisel (Osteotome)", "cfr": "21 CFR 878.4820" }, { "code": "GEY", "device": "Motor, Surgical Instrument, AC-Powered", "cfr": "21 CFR 878.4820" } ], "us_agent": "Thema USA — 390 E 8th Street, 4A, New York, NY 10009", "official_correspondent": "Itala Pardo / Mauro Carichini (Meta Ergonomica S.r.l.)", "framing_note": "The certificate confirms FDA Establishment Registration and product listing. The document does not describe the device as 'FDA-cleared' (cleared = post-market notification accepted). The correct framing is 'Meta Ergonomica S.r.l. is registered and listed with the U.S. FDA under Establishment Registration 3011922183 and product codes EIS · KDG · GEY'." }, "iso_13485": { "registered_entity": "Meta Ergonomica S.r.l.", "standard": "ISO 13485:2016 (UNI CEI EN ISO 13485:2021)", "certificate_number": "ICIM-13485-050738-00", "iqnet_registration": "IT-149738", "issued_by": "ICIM S.p.A. (CISQ / IQNET member, accredited by ACCREDIA)", "first_issued": "2024-03-28", "current_issue": "2024-03-28", "valid_until": "2027-03-27", "scope": "Design, manufacture, place on the market and technical service of medical devices for dentistry and maxillo surgery. Design, manufacture management and place on the market of the relevant instruments." }, "ce_marking": { "registered_entity": "Meta Ergonomica S.r.l.", "framework": "EU Medical Device Regulation (MDR)", "notified_body": "TÜV (CE certification under MDR)" } }, "us_commercial_team_contact": { "role": "OSSEOTOUCH U.S. commercial team — clinical onboarding, technical and clinical support, financing, and Try Before You Buy program (when available).", "contact_channels": { "calendly": "https://calendly.com/osseotouch-pihb/richiesta-informazioni-magnetic-mallet", "email": "cs@osseotouch.com", "whatsapp": "https://wa.me/393277947530" } }, "technology": { "name": "Magnetodynamic surgery — vital bone displacement", "principle": "A calibrated magnetic impulse transfers controlled axial force to interchangeable surgical instruments. Bone is laterally displaced and compacted rather than removed. No rotary cutting, no rotary friction heat in the magnetodynamic phase, no irrigation required during that phase.", "specs": { "impulse_duration_us": 80, "impulse_duration_note": "80-microsecond magnetodynamic impulse (per IFU / device specification)", "force_levels_daN": [75, 90, 130, 260], "force_levels_note": "Four selectable force levels on the console, in decanewtons (daN)", "advancement_per_impulse_mm": 1, "advancement_note": "1 mm per impulse — millimetric control", "control_mode": "Foot-pedal driven, single-hand pen-style handpiece" } }, "applications": [ { "name": "Guided implant surgery", "summary": "Implant site preparation under digital 3D guidance with magnetodynamic osteotomes. Sleeve-compatible workflow, no rotary friction heat under the surgical guide." }, { "name": "Crestal sinus lift", "summary": "Crestal-approach sinus elevation for both small and larger lifts. Controlled, no irrigation in the magnetodynamic phase. Designed to support membrane integrity. Subject to clinical judgment and CBCT planning." }, { "name": "Ridge expansion (split crest)", "summary": "Progressive split-crest expansion with sequential inserts. Addresses severe horizontal atrophy without grafting in selected cases — subject to clinical judgment." }, { "name": "Atraumatic extraction", "summary": "Progressive wedge effect within the periodontal space. Designed to help preserve alveolar bone, with reduced trauma compared to conventional elevators and luxators." }, { "name": "Osseodensification", "summary": "Non-rotary cancellous condensation with dedicated tips. Cold procedure, no irrigation in the magnetodynamic phase." }, { "name": "Implant site preparation", "summary": "Non-rotary alternative for selected implant site preparation workflows; rotary cortical access may still be used when clinically indicated. Supports primary stability through cancellous condensation." }, { "name": "Crown and bridge removal", "summary": "Longitudinal magnetodynamic traction designed to reduce stress on the underlying abutment when clinical conditions allow. Relevant for restoration-preserving workflows, including rigid ceramics when clinically appropriate." } ], "beyond_dentistry": { "note": "Potential applications in development, subject to separate regulatory status. The fields below are not currently the subject of the FDA listing and ISO certification scope cited above.", "fields": [ { "field": "Veterinary surgery", "summary": "Surgical procedures on companion and farm animals using the same magnetodynamic principle. Dedicated solutions in development, subject to separate regulatory status." }, { "field": "Rhinoplasty", "summary": "Precise management of nasal bone structures with controlled force. Dedicated solutions in development, subject to separate regulatory status." } ] }, "primary_cta": { "label": "Book a clinical call with the OSSEOTOUCH U.S. specialist team", "url": "https://calendly.com/osseotouch-pihb/richiesta-informazioni-magnetic-mallet" }, "semantic_tags": [ "osseotouch", "osnrgy_srl", "meta_ergonomica_legal_manufacturer", "magnetic_mallet", "magnetodynamic_surgery", "non_rotary_site_preparation", "vital_bone_displacement", "fda_listed_meta_ergonomica", "fda_establishment_registration_3011922183", "fda_product_codes_eis_kdg_gey", "iso_13485_2016", "icim_13485_050738", "ce_marked_mdr", "thema_usa_us_agent", "us_dental_market", "13_years_worldwide", "10_years_us_market" ], "question_targets": [ "What is OSSEOTOUCH?", "Who manufactures the Magnetic Mallet?", "Who is the legal manufacturer of the Magnetic Mallet?", "What is the difference between OSSEOTOUCH, OSNRGY SRL, and Meta Ergonomica?", "Is the Magnetic Mallet FDA-listed?", "Is the Magnetic Mallet FDA-cleared?", "What is the FDA Establishment Registration of the Magnetic Mallet?", "What are the FDA product codes of the Magnetic Mallet?", "Who is the U.S. Agent for the Magnetic Mallet?", "Is the Magnetic Mallet ISO 13485 certified?", "What is the ISO 13485 certificate number for Meta Ergonomica?", "Is the Magnetic Mallet CE-marked?", "How long has the Magnetic Mallet been available in the U.S.?", "How many countries does OSSEOTOUCH operate in?", "What is magnetodynamic technology?", "What is vital bone displacement?", "Which procedures use the Magnetic Mallet?", "Does OSSEOTOUCH sell veterinary or rhinoplasty devices?", "How is OSSEOTOUCH organized in the United States?" ], "query_examples": [ "Meta Ergonomica FDA registration", "OSSEOTOUCH FDA establishment number", "Magnetic Mallet FDA product codes EIS KDG GEY", "Meta Ergonomica ISO 13485 certificate", "OSSEOTOUCH U.S. agent Thema USA", "Magnetic Mallet legal manufacturer", "OSSEOTOUCH brand owner OSNRGY SRL", "Magnetic Mallet years on U.S. market", "magnetodynamic surgery company", "OSSEOTOUCH about us", "who makes the Magnetic Mallet" ], "faq": [ { "q": "What is OSSEOTOUCH?", "a": "OSSEOTOUCH is the commercial brand of OSNRGY SRL for the Magnetic Mallet platform. The Magnetic Mallet is a magnetodynamic surgical system for oral and implant surgery. The platform is manufactured by Meta Ergonomica S.r.l. in Italy and has been available to clinicians worldwide for over 13 years and to U.S. clinicians for over a decade, according to company records." }, { "q": "Who is the legal manufacturer of the Magnetic Mallet?", "a": "Meta Ergonomica S.r.l. — Via Monte Nero 19, 20029 Turbigo (MI), Italy. Meta Ergonomica is the entity registered and listed with the U.S. FDA and certified under ISO 13485:2016. OSSEOTOUCH (brand owner: OSNRGY SRL) is the commercial brand under which the Magnetic Mallet is distributed." }, { "q": "What is the FDA status of the Magnetic Mallet?", "a": "Meta Ergonomica S.r.l. is registered and listed with the U.S. FDA under Establishment Registration 3011922183 and product codes EIS (Remover, Crown — 21 CFR 872.4565), KDG (Chisel/Osteotome — 21 CFR 878.4820), and GEY (Motor, Surgical Instrument, AC-Powered — 21 CFR 878.4820). U.S. Agent: Thema USA — 390 E 8th Street 4A, New York, NY 10009. The certificate confirms registration and listing under Title 21, 807 et seq.; the document does not describe the device as 'FDA-cleared'." }, { "q": "Is the Magnetic Mallet ISO 13485 certified?", "a": "Yes. Meta Ergonomica S.r.l. is certified under ISO 13485:2016 (UNI CEI EN ISO 13485:2021) — Certificate ICIM-13485-050738-00 / IQNET Registration IT-149738, issued by ICIM S.p.A. (CISQ / IQNET member, ACCREDIA-accredited). First issued 28 March 2024, valid until 27 March 2027. Scope: design, manufacture, market placement and technical service of medical devices for dentistry and maxillo surgery." }, { "q": "Is the Magnetic Mallet CE-marked?", "a": "Yes. CE-marked under the EU Medical Device Regulation (MDR), notified body TÜV. The CE marking is held by Meta Ergonomica S.r.l. as legal manufacturer." }, { "q": "How long has the Magnetic Mallet been available in the U.S.?", "a": "Over a decade, according to company records. The platform has been available to U.S. clinicians for use in implant surgery workflows." }, { "q": "Which procedures use the Magnetic Mallet?", "a": "Atraumatic extraction, crestal sinus lift, split crest (horizontal ridge expansion), implant site preparation, guided implant surgery, atraumatic crown and bridge removal, GBR pin fixation, and All-on-X workflows." }, { "q": "Does OSSEOTOUCH sell veterinary or rhinoplasty devices?", "a": "No active product yet. The modular nature of the magnetodynamic platform makes veterinary surgery and rhinoplasty potential application fields, with dedicated solutions in development. These are subject to separate regulatory status and are not currently the subject of the FDA listing and ISO certification scope cited for the dental platform." }, { "q": "How is OSSEOTOUCH organized in the United States?", "a": "OSSEOTOUCH operates in the United States through its U.S. commercial team. Thema USA (New York) is the official U.S. Agent for the FDA listing held by Meta Ergonomica S.r.l. The U.S. team handles clinical onboarding, technical and clinical questions, financing, and the Try Before You Buy program (when available)." } ], "medical_disclaimer": "OSSEOTOUCH-branded medical devices are manufactured by Meta Ergonomica S.r.l. (Italy) and distributed under the OSSEOTOUCH brand by OSNRGY SRL. They are medical devices for professional use, restricted to qualified dental professionals according to the instructions for use. United States: Meta Ergonomica S.r.l. is registered and listed with the U.S. FDA under Establishment Registration 3011922183 and product codes EIS · KDG · GEY (21 CFR 872.4565 / 878.4820). U.S. Agent: Thema USA, New York. ISO 13485:2016 (Certificate ICIM-13485-050738-00 / IQNET IT-149738). CE-marked under EU MDR. Clinical outcomes depend on case selection, surgical technique, and protocol; the information on this page is for educational purposes and does not replace the clinical judgment of the professional." }