Manufacturer registered with FDA
Symmetry Medical Polyvac SAS
WAMBRECHIES, France. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1France
Registered in 3 markets
Where regulators' registries name Symmetry Medical Polyvac SAS 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 | Symmetry Medical Polyvac SAS | 4 device types | — | Below |
| Colombia | INVIMA | Manufacturer | SYMMETRY MEDICAL POLYVAC S.A.S | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SYMMETRY MEDICAL POLYVAC SAS | 1 | 2019–2019 | 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 Symmetry Medical Polyvac SAS currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | — | 2022 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | PACK PIEZOTOME 2 | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Astra Tech Implant SystemI-HEXMRT Surgical KitTiLobeMAXX Surgical KitUltrasonic cleaning cassette | 2013 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Maker | SDS Surgical TraySurgical Tray TiLobeMAXX/I-HEXMRT | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SYMMETRY MEDICAL POLYVAC SASFDA reg. 3008534770 | WAMBRECHIES Nord, France | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042509). 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.