Manufacturer registered with FDA
Amann Girrbach AG
Maeder, Austria. Lists 19 dental device types with FDA across 2 registered establishments, and holds 3 510(k) clearances as applicant.
- Device types listed
- 19
- Brands and models
- 47
- 510(k) clearances
- 32017–2026
- Markets registered in
- 15204 registrations outside the US
- Establishments
- 2Austria, United States
510(k) clearances per year, 2007–2026
Registered in 15 markets
Where regulators' registries name Amann Girrbach 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 | Amann Girrbach AG | 3 clearances | 2017–2026 | Below |
| South Korea | MFDS | Manufacturer | Amann Girrbach AGAmannGirrbach AG · AMANNGIRRBACH | 45 | 2001–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | AMANN GIRRBACH AG | 31 | 2010–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Amann Girrbach AG | 30 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Amann Girrbach AG | 25 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | AMANN GIRRBACH AGAmann Girrbach AG | 21 | 2010–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | AMANN GIRRBACH AG | 18 | 2011–2026 | Pure Global AI |
| European Union | EUDAMED | Registration holder | Amann Girrbach AG | 11 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Amann Girrbach AgAmannGirrbach AG | 7 | 2013–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Amann Girrbach AG | 7 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | AMANN GIRRBACH AG | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Amann Girrbach AG | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 阿曼吉尔巴赫股份有限公司Amann Girrbach AG | 1 | — | Pure Global AI |
| Japan | PMDA | Registration holder | Ａｍａｎｎ Ｇｉｒｒｂａｃｈ ＡＧ | 1 | 2026–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Amann Girrbach AG | 1 | 2022–2022 | 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 Amann Girrbach 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Ceramill HT+ PSCeramill HT+ whiteCeramill LiquidCeramill Liquid fxCeramill Liquid new formulaCeramill ZICeramill ZI CAMCeramill Zolid fxCeramill Zolid fx MLZolid Bion 3 moreZolid DRSZolid gen-xZolid Lunaris | 2007 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Ceramill A-TempCeramill A-Temp ML | 2019 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | — | 2021 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | — | 2021 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | Ceramill Sintron | 2006 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | Artex BNArtex CNArtex CPArtex CPRArtex CRArtex CR Limited Edition GoldArtex CT | 2010 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | Artex facebowArtex QuickbiteAxis plane pointer with screwBite fork partialBite fork totalClinometerJoint supportLeipzig NasionNasion vertically adjustablePorus buttons long 1 moreTray handle | 2006 |
| Jaw Tracking Device for Monitoring Jaw PositionsNFS · Class 1 | — | Lister | — | 2022 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | 179130 Ceramill Map 200179130-IDC IDC S2179130NC Ceramill Map 200+179140 Ceramill Map 400179140-IDC IDC S1179140NC Ceramill Map 400+179560 Ceramill Map 600179560-IDC IDC S3179560N Ceramill Map600+179570 Ceramill Map FX | 2015 |
| Resin Long-Term Temporary Crown and BridgePOW · Class 2 | — | Maker | Ceramill A-TempCeramill A-Temp ML | 2019 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Lister | NextDent Ortho Flex | 2021 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | — | 2024 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | — | 2012 |
| Shellac Base PlateEEA · Class 1 | — | Lister | — | 2021 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | — | 2024 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Lister | — | 2024 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Lister | — | 2021 |
| Backing and Facing Artificial TeethELK · Class 1 | — | Lister | — | 2021 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | — | 2012 |
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 Amann Girrbach AG as the applicant, including filings under its other names.
Also lists devices cleared under other names
Amann Girrbach AG 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: Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (3), Vertex-Dental B.V. (1), Juvora, Ltd. (1), Emergo Europe Consulting (1), Amann Girrbach America, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Nov 2019 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | EBI Rebasing Repairing Relining Denture Resin |
| 21 Dec 2018 | K181331 | JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White | Juvora, Ltd. | EBI Rebasing Repairing Relining Denture Resin |
| 21 Sep 2015 | K152383 | Ceramill Zolid FX | Emergo Europe Consulting | EIH Porcelain Powder |
| 31 Jan 2014 | K132070 | VITA SUPRINITY(R) | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | EIH Porcelain Powder |
| 13 Dec 2012 | K122269 | ENAMIC | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | EIH Porcelain Powder |
| 11 Aug 2010 | K102128 | VITABLOCS | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | EIH Porcelain Powder |
| 2 Feb 2007 | K063511 | CERAMILL ZI | Amann Girrbach America, Inc. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Amann Girrbach AGFDA reg. 3030515618 | Maeder Vorarlberg, Austria | Complaint file establishment, Foreign exporter, Manufacturer, Private-label distributor |
| Amann Girrbach North America, LPFDA reg. 3005942449 | Charlotte, NC, United States | Complaint file establishment |
Other names on FDA records
Amann Girrbach North America, LP
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9093103). 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.