Registered with FDA
Piezosurgery, Inc DBA Mectron North America
Hilliard, OH, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Piezosurgery, Inc DBA Mectron North America currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | MT-BonePiezosurgery //Piezosurgery 3Piezosurgery FlexPiezosurgery GP DevicePiezosurgery MedicalPiezosurgery PlusPiezosurgery Touch | 2013 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | COMPACT PIEZO LEDMT-BoneMULTIPIEZO, MULTIPIEZO PROPiezosurgery //Piezosurgery GP DevicePiezosurgery Touch | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Piezosurgery, Inc DBA Mectron North America lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Mectron S.P.A. (5), Piezosurgery S.R.L. (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Aug 2024 | K242432 | MT-Bone | Mectron S.P.A. | DZI Powered Bone Drill |
| 4 Sep 2015 | K151248 | PIEZOSURGERY WHITE | Mectron S.P.A. | DZI Powered Bone Drill |
| 5 Aug 2015 | K151023 | COMPACT PIEZO LED | Mectron S.P.A. | ELC Ultrasonic Scaler |
| 20 Aug 2014 | K140965 | MULTIPIEZO PRO, MULTIPIEZO | Mectron S.P.A. | ELC Ultrasonic Scaler |
| 6 Dec 2012 | K122322 | PIEZOSURGERY TOUCH | Mectron S.P.A. | DZI Powered Bone Drill |
| 29 Dec 2009 | K091227 | PIEZOSURGERY 3; OSSTEM PIEZO | Piezosurgery S.R.L. | DZI Powered Bone Drill |
| 16 Nov 2005 | K052518 | PIEZOSURGERY | Piezosurgery S.R.L. | ELC Ultrasonic Scaler |
| 8 Jun 2005 | K043408 | PIEZOSURGERY DEVICE | Piezosurgery S.R.L. | DZI Powered Bone Drill |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Mectron North AmericaFDA reg. 3005282635 | Hilliard, OH, United States | Complaint file establishment |
Other names on FDA records
Mectron North America
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9075679). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.