Manufacturer registered with FDA
Mectron S.P.A.
CARASCO, Italy. Lists 5 dental device types with FDA across 1 registered establishment, and holds 11 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 29
- 510(k) clearances
- 112009–2025
- Markets registered in
- 16264 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2000–2026
Registered in 16 markets
Where regulators' registries name Mectron S.P.A. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Mectron S.P.A. | 11 clearances | 2009–2025 | Below |
| Canada | Health Canada | Registration holder | MECTRON S.P.A. | 85 | 2006–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Mectron S.p.AMECTRON SRL · Mectron S.p.A. · +2 | 53 | 2001–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Mectron S.p.A | 33 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Mectron S.p.A. | 18 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MECTRON S.P.AMECTRON S.P.A. | 14 | 2012–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MECTRON S.P.A.MECTRON SPA · MECTRON S.p.A. · +1 | 14 | 2005–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Mectron SPA | 13 | 2004–2022 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | MECTRON S.p.A | 13 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Mectron S.p.A.Mectron S.P.A · Mectron SPA | 9 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | MECTRON S.p.A. | 4 | 2024–2024 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MECTRON S.p.A | 3 | 2017–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Mectron S.p.A. | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 迈超股份公司MECTRON S.p.A | 1 | — | Pure Global AI |
| Japan | PMDA | Registration holder | Ｍｅｃｔｒｏｎ Ｓ．ｐ．Ａ | 1 | 2021–2021 | Pure Global AI |
| Philippines | FDA Philippines | Manufacturer | Mectron S.p.A. | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Mectron S.P.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | combi touchCOMPACT PIEZO LEDCompact Piezo P2K - PowercareK10K6MT-BoneMULTIPIEZO PRO - MULTIPIEZOP15P16LP16R 3 morePIEZOSURGERY GPPIEZOSURGERY TOUCHSLIM SCALER HANDPIECE | 2011 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | combi touchMT-BoneMT11L-10MT11R-10PIEZOSURGERY 3 - OSSTEMPIEZOPIEZOSURGERY 3 10th ANNIVERSARY LIMITED EDITIONPIEZOSURGERY FLEXPIEZOSURGERY GPPIEZOSURGERY PLUSPIEZOSURGERY TOUCH | 2010 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | SilverlightStarlight Pro | 2009 |
| AirbrushKOJ · Class 2 | — | Maker | combi touch | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | BONE EXPANDERSSINUS PHYSIOLIFTSINUS PHYSIOLIFT II | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Mectron S.P.A. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 May 2025 | K251425 | turbodent touch | KOJ Airbrush |
| 19 Aug 2024 | K242432 | MT-Bone | DZI Powered Bone Drill |
| 15 May 2023 | K231391 | Combi Touch | ELC Ultrasonic Scaler |
| 13 Apr 2018 | K171326 | Piezosurgery White | DZI Powered Bone Drill |
| 12 Jan 2018 | K171958 | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | DZI Powered Bone Drill |
| 4 Sep 2015 | K151248 | PIEZOSURGERY WHITE | DZI Powered Bone Drill |
| 5 Aug 2015 | K151023 | COMPACT PIEZO LED | ELC Ultrasonic Scaler |
| 20 Aug 2014 | K140965 | MULTIPIEZO PRO, MULTIPIEZO | ELC Ultrasonic Scaler |
| 6 Dec 2012 | K122322 | PIEZOSURGERY TOUCH | DZI Powered Bone Drill |
| 24 Jan 2011 | K102218 | COMPACT PIEZO P2K, POWERCARE | ELC Ultrasonic Scaler |
| 7 Dec 2009 | K092951 | STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS | EBZ Ultraviolet Activator for Polymerization |
Some of these clearances are listed with FDA today by another company: Hu-Friedy Mfg Co., LLC (3), GC America Inc. (1), Kulzer, LLC (1).
Also lists devices cleared under other names
Mectron S.P.A. 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: Piezosurgery S.R.L. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Dec 2009 | K091227 | PIEZOSURGERY 3; OSSTEM PIEZO | Piezosurgery S.R.L. | DZI Powered Bone Drill |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MECTRON S.P.A.FDA reg. 3003933619 | CARASCO Genova, Italy | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9078459). 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.