Manufacturer registered with FDA
Zirkonzahn Srl
Gais, Italy. Lists 14 dental device types with FDA across 1 registered establishment, and holds 10 510(k) clearances as applicant.
- Device types listed
- 14
- Brands and models
- 6
- 510(k) clearances
- 102006–2023
- Markets registered in
- 132,236 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2000–2026
Registered in 13 markets
Where regulators' registries name Zirkonzahn Srl 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 | Zirkonzahn Srl | 10 clearances | 2006–2023 | Below |
| Canada | Health Canada | Registration holder | ZIRKONZAHN SRL | 1,998 | 2009–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Zirkonzahn SRL | 114 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Zirkonzahn srl | 35 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | ZIRKONZAHN s.r.lZirkonzahn srl · ZIRKONZAHN s.r.l. · +2 | 30 | 2006–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Zirkonzahn SRL | 21 | 2019–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ZIRKONZAHN SRL | 11 | 2012–2023 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Zirkonzahn Srl | 9 | 2025–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ZIRKONZAHN SRLZIRKONZAHN GMBH/ SRL | 6 | 2011–2021 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Zirkonzahn Srl | 4 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Zirkonzahn SRL | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Zirkonzahn srlZirkonzahn Srl | 3 | — | Pure Global AI |
| China | NMPA | Registration holder | 泽康赞有限责任公司Zirkonzahn Srl | 2 | — | 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 Zirkonzahn Srl currently lists, by FDA device type, with the brand and model names on the listing.
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 Zirkonzahn Srl as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 Sep 2023 | K232691 | Polibond | EBI Rebasing Repairing Relining Denture Resin |
| 14 Dec 2022 | K213722 | ICE Ceramics, ICE Stains, Fresco | EIH Porcelain Powder |
| 8 Jul 2020 | K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | EBG Resin Temporary Crown and Bridge |
| 22 Nov 2019 | K190518 | Color Liquid, Vita Liquid | EIH Porcelain Powder |
| 4 Apr 2019 | K183304 | Prettau, ICE, Z-White zirconia blanks | EIH Porcelain Powder |
| 28 Jun 2018 | K180562 | TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT | EBG Resin Temporary Crown and Bridge |
| 18 Jun 2018 | K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue | EBF Resin Tooth Shade Material |
| 8 Oct 2015 | K151490 | PRETTAU ANTERIOR T0 | EIH Porcelain Powder |
| 5 Nov 2014 | K132230 | ICE ZIRKON TRANSLUZENT | EIH Porcelain Powder |
| 29 Sep 2006 | K061851 | ZIRKONZAHN ICE | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ZIRKONZAHN SRLFDA reg. 3005904906 | Gais Bolzano, Italy | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9089299). 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.