Manufacturer registered with FDA
Nouvag AG
GOLDACH, Switzerland. Lists 2 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 9
- 510(k) clearances
- 42003–2008
- Markets registered in
- 659 registrations outside the US
- Establishments
- 1Switzerland
510(k) clearances per year, 2000–2026
Registered in 6 markets
Where regulators' registries name Nouvag AG 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 | Nouvag AG | 4 clearances | 2003–2008 | Below |
| Taiwan | TFDA | Manufacturer | NOUVAG AGNOUVAG AG. · Nouvag AG | 27 | 2005–2020 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NOUVAG AG | 17 | 2020–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | Nouvag AGNOUVAG AG | 7 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NOUVAG AG | 5 | 2021–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | NOUVAG AG | 3 | — | 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 Nouvag AG 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 | Maker | Handpieces ENTHighSurg 30MD 11MD 30 | 2007 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Clip for external coolingClip for internal coolingContra angleHandpieceY-Connector | 2007 |
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 Nouvag AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Aug 2008 | K081191 | TCM ENDO 20 | EKX Ac-Powered Direct Drive Handpiece |
| 22 Dec 2004 | K042822 | TCM ENDO V, MODEL 1534 | EKX Ac-Powered Direct Drive Handpiece |
| 3 Nov 2004 | K042434 | MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 | DZI Powered Bone Drill |
| 1 Oct 2003 | K022505 | CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NOUVAG AGFDA reg. 9680741 | GOLDACH Sankt Gallen, Switzerland | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9008454). 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.