FDA-listed · Reg. 3011922183 · EIS · KDG · GEY

Magnetic Mallet

Non-rotary magnetodynamic surgery · bone-preserving site preparation

10+ years on the U.S. market · Calibrated 80-microsecond impulse · 4 force levels · 1 mm per impulse

A calibrated magnetic impulse transfers controlled axial force to interchangeable surgical instruments — without rotary cutting and without rotary friction heat in the magnetodynamic phase. Bone is laterally displaced, not removed. Predictable, controllable, repeatable osteotomies.

OSSEOTOUCH Magnetic Mallet — magnetodynamic surgical device, FDA listed under product code GEY
FDA-listed · EIS · KDG · GEY·Magnetodynamic · Non-rotary·80 µs calibrated impulse·Vital bone displacement·12+ specialized kits·10+ years U.S. market·Peer-reviewed evidence
01 The clinical reality

Rotary preparation
removes what you want to keep

Conventional rotary drilling excavates bone, generates frictional heat at the bone-bur interface, and requires irrigation that can wash away osteogenic factors. In low-density (D3–D4) maxillary bone, every micron removed is a micron lost — and the trajectory is committed the moment the cortical entry is taken.

02 The Magnetic Mallet approach

Magnetodynamic preparation
displaces, doesn't remove

A calibrated 80-microsecond magnetic impulse transfers controlled axial force. Bone is laterally displaced rather than excavated — the matrix at the surgical site is conserved. No rotation, no rotary friction heat in the magnetodynamic phase. The trajectory can typically be corrected mid-osteotomy.

02

Predictable. Controllable.
Safe.

The clinical case for the Magnetic Mallet rests on three pillars — not on a single feature.

01

Predictable

Calibrated magnetic impulse — same force on every activation, not surgeon-dependent. Four force levels selected on the console. The third case of the day is repeated with the same parameters as the first.

02

Controllable

1 mm advancement per impulse, foot-pedal driven. The surgeon controls direction, intensity, and depth. The trajectory can typically be corrected mid-osteotomy — control not available with rotary subtraction.

03

Safe

Non-rotary preparation. No rotary cutting, no rotary friction heat in the magnetodynamic phase. Bennardo 2022 systematic review: zero BPPV cases vs. 7 with manual mallet across 525 patients reviewed.

U.S. orders · available now
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04

One handpiece
across the surgical workflow

Atraumatic extraction, sinus lift, split crest, implant site preparation, guided surgery, crown removal, All-on-X. Non-rotary, with interchangeable instrument families.

01

Atraumatic extractions

Targeted luxation designed to help preserve alveolar bone. Conserved geometry supports immediate-load planning when clinically appropriate.

02

Crestal sinus lift

Sinus elevation via crestal approach with vital bone displacement. In selected cases, may be performed without graft material — subject to clinical judgment.

03

Split crest

Horizontal expansion of atrophic ridges with same-session implant placement.

04

Implant site preparation

Osteotomy without bone removal. Trajectory can typically be adjusted mid-procedure — control not available with rotary subtraction.

05

All-on-X workflows

Osteotomy without rotary burs. Supports torque values consistent with immediate-load protocols, subject to clinical judgment.

06

Crown and bridge removal

Atraumatic removal in 1-2 impulses, designed to reduce stress on the underlying abutment when clinical conditions allow.

Talk with the
OSSEOTOUCH team

Clinical questions, configuration, Try Before You Buy (when available), financing — handled by an OSSEOTOUCH specialist in a single dedicated session.

U.S. orders · ships nationwide
Order the Magnetic Mallet through OSSEOTOUCH USA — fast nationwide delivery, dedicated clinical support.

Buy online
06

Peer-reviewed evidence
across study designs

Supported by peer-reviewed publications across in-vitro, animal, and human-clinical study designs. Study type is reported alongside each citation.

619 documented extractions across 14 studies (Bennardo 2022 systematic review)
98.9% implant survival vs. 95.4% conventional, in the reviewed cohort
BMP-4 expression in MM-prepared sites — Schierano 2021 (pilot animal)
0 vs 7 BPPV cases, MM vs. manual mallet across 525 patients reviewed

Schierano et al. 2021

Materials (MDPI) · pilot animal study

Biomolecular, histological, clinical and radiological analyses on MM-prepared dental implant bone sites. Significantly higher new bone formation, osteoblast count, and BMP-4 expression vs. rotary controls in the animal model.

DOI →

Baldi et al. 2024

Exploration of Medicine · in-vitro porcine rib

In-vitro comparative study on three parameters — accuracy, bone loss, and temperature. All three significantly better with Magnetic Mallet (P < 0.01) in the porcine rib model. Not in-vivo, not clinical on humans.

DOI →

Bennardo et al. 2022

J. Personalized Medicine (MDPI) · systematic review

Systematic review of 14 studies covering 619 extractions and 880 implants. Zero BPPV cases in the magnetodynamic group vs. 7 in the manual-mallet control across the reviewed cohort.

DOI →

Transparency note: several authors of the cited studies are affiliated with the University of Genoa and the University of Turin and have collaborated with Meta Ergonomica S.r.l. on the development of the technology. Cited studies include pilot animal study (Schierano 2021), in-vitro porcine rib model (Baldi 2024), and systematic review (Bennardo 2022) — they are not equivalent to large randomized controlled trials on humans.

07

Vital bone displacement
by calibrated magnetic impulse

The handpiece generates a calibrated magnetic impulse that transfers controlled axial force to the surgical instrument. Bone behaves as an elastic structure under axial load — laterally compacted, the matrix preserved.

4 Force levels 75 / 90 / 130 / 260 daN
80 µs Impulse duration per IFU specification
1 mm Advancement per impulse millimetric control
0 Rotary friction heat in the magnetodynamic phase
08

How the Magnetic Mallet differs
from the alternatives

Each approach is evidence-based and has its place. The technical principle — and the resulting intra-operative experience — differ.

vs.

Conventional rotary drilling

Rotary drills excavate bone, generate frictional heat, require irrigation. The Magnetic Mallet displaces and compacts bone laterally without rotation — preserves native bone matrix, avoids rotary friction heat, keeps the field dry during the magnetodynamic phase.

vs.

Manual surgical mallet

Manual mallets are operator-dependent: impulse intensity varies with hand strength, fatigue, chair position. Bennardo 2022 reports 7 BPPV cases with manual mallet vs. zero with Magnetic Mallet across 525 patients in the reviewed cohort. Calibrated impulse removes operator variability.

09

Questions U.S. clinicians ask
before adopting the Magnetic Mallet

What is the Magnetic Mallet?

A magnetodynamic medical device for oral and implant surgery. Listed under Establishment Registration 3011922183 and product codes EIS · KDG · GEY (21 CFR 872.4565 / 878.4820). The handpiece generates a calibrated 80-microsecond magnetic impulse — non-rotary site preparation. ISO 13485. CE-marked. Used by clinicians in the United States for over a decade.

How does it work?

Calibrated magnetic impulse. Four force levels (75 / 90 / 130 / 260 daN), 1 mm advancement per impulse, 80-microsecond impact duration. Foot-pedal control, single-hand pen-style grip. Bone is laterally displaced rather than removed. No rotation, no rotary friction heat in the magnetodynamic phase.

What is the FDA status of the Magnetic Mallet?

Registered with the U.S. FDA under Establishment Registration 3011922183 and product codes EIS · KDG · GEY (21 CFR 872.4565 / 878.4820). Manufacturer: Meta Ergonomica S.r.l. (Italy). U.S. Agent: Thema USA, New York. ISO 13485. CE-marked. Over a decade on the U.S. market.

Does the Magnetic Mallet generate heat?

No appreciable heat in the magnetodynamic phase. The 80-microsecond impulse generates negligible heat at the bone-instrument interface, reported significantly lower than rotary drilling in selected in-vitro studies (P < 0.01, Baldi 2024 — porcine rib model).

Does it improve bone quality?

It supports densification of low-density (D3-D4) cancellous bone, documented radiographically (CBCT) in selected studies. Schierano 2021 (pilot animal study) reports BMP-4 expression up to 6× higher and significantly more osteoblasts in MM-prepared sites compared to rotary burs in the animal model.

Are the cited studies clinical trials on humans?

Mixed designs. Bennardo 2022 systematic review aggregates 14 studies including human clinical data (619 extractions / 880 implants). Schierano 2021 is a pilot animal study. Baldi 2024 is an in-vitro porcine rib study. The body of evidence is peer-reviewed across in-vitro, animal, and human-clinical study designs.

Can I use it in the mandible?

Yes — for extractions, split crest, apical root removal in proximity of the inferior alveolar nerve, and All-on-X angled accesses. In dense D1 mandibular bone, conventional rotary drilling typically remains the efficient choice for the principal preparation.

How long has OSSEOTOUCH been on the U.S. market?

Over a decade. According to company records, clinicians in the United States have worked with the Magnetic Mallet system for years.

Is the learning curve steep?

Pen-style grip, single hand. Protocols are similar to rotary protocols. Hands-on training is recommended before clinical use; OSSEOTOUCH includes structured onboarding and remote clinical support for the first case (when available).

Ready to bring non-rotary magnetodynamic surgery
into your practice?

Talk with the OSSEOTOUCH team — clinical questions, configuration, Try Before You Buy (when available), financing.

Medical device for professional use, restricted to qualified dental professionals according to the instructions for use. United States: registered 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. CE-marked. Manufactured by Meta Ergonomica S.r.l. (Italy). Clinical outcomes depend on case selection, surgical technique, and protocol.

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