Manufacturer registered with FDA
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
BAD SACKINGEN, Germany. Lists 14 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 14
- Brands and models
- 48
- 510(k) clearances
- 82009–2026
- Markets registered in
- 152,345 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2000–2026
Registered in 15 markets
Where regulators' registries name Vita Zahnfabrik H. Rauter GmbH & Co. Kg. as the manufacturer or the registration holder of a device.
RegisteredHome: GermanyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 8 clearances | 2009–2026 | Below |
| European Union | EUDAMED | Manufacturer | VITA Zahnfabrik H. Rauter GmbH & Co. KG | 1,709 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | VITA ZAHNFABRIK, H. RAUTER GMBH & CO. KG | 301 | 1999–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | VITA Zahnfabrik H.Rauter GmbH & Co. KGVITA Zahnfabrik H. Rauter GmbH & Co. KG · VITA Zahnfabrik H. Rauter GmbH & Co.KG · +2 | 74 | 2000–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | VITA Zahnfabrik H. Rauter GmbH & Co. KGVITA Zahnfabrik H. Rauter GmbH & CO. KG · VITA ZAHNFABRIK H.RAUTER GMBH & CO., KG · +1 | 57 | 2006–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | VITA Zahnfabrik H. Rauter GmbH & Co.KG | 51 | 2023–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | VITA Zahnfabrik H. Rauter GmbH & Co. KG | 34 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG | 27 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | VITA Zahnfabrik H Rauter GmbH & Co.KGVita Zahnfabrik, H.Rauter GmbH & Co.KG | 26 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Vita Zahnfabrik H Rauter GmbH & Co KG | 21 | 2005–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | VITA ZAHNFABRIK H. RAUTER GMBH & CO. KGVITA ZAHNFABRIK, H. RAUTER GMBH & CO. KG | 19 | 1999–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | VITA Zahnfabrik H. Rauter GmbH & Co.Vita Zahnfabrik H. Rauter GmbH & Co. KG | 12 | — | Pure Global AI |
| China | NMPA | Registration holder | 德国维他公司VITA Zahnfabrik,H. Rauter GmbH & Co.KG德国维他公司VITA Zahnfabrik, H. Rauter GmbH & Co. KG · 德国维他公司VITA Zahnfabrik,H.Rauter GmbH & Co.KG · +2 | 10 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | VITA Zahnfabrik H. Rauter GmbH & Co. KG | 3 | — | Pure Global AI |
| Japan | PMDA | Registration holder | ＶＩＴＡ Ｚａｈｎｆａｂｒｉｋ， Ｈ． Ｒａｕｔｅｒ ＧｍｂＨ ＆ Ｃｏ． ＫＧ | 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 Vita Zahnfabrik H. Rauter GmbH & Co. Kg. 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 | Celay Blanks Celay OptimizerHi-CeramIn-Ceram AL CubeIn-Ceram AluminaIn-Ceram SpinellIn-Ceram YZ, YZ T and YZ HTn!ce Zirconia GTOmega Omega 800 Omega 900PM7 PM9Response 16 moreTitaniumVITA AmbriaVITA ENAMIC BlocksVITA LumexVITA SUPRINITYVITA VMK Master, NP BondVITA YZ Multi TranslucentVITA YZ ST and VITA YZ XT VITA YZ ST Multicolor and VITA YZ XT MulticolorVitablocs, Triluxe, Triluxe ForteVITAchrom-L Interno Akzent, AL Coloring Liquid, YZ Coloring LiquidVITAdur Alpha Ceramic DVITAdur-NVM7, VM 8, VM9, VM11, VM13, VM15VMK68 VMK68N VMK95YZ SHADE LIQUID, YZ EFFECT LIQUIDYZ ST & XT SHADE LIQUIDS | 2007 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | ADIVA FCEMVITA ENAMIC BlocksVITA Vionic Dent Disc ResinVM LC FlowZeta LC Zeta CC Zeta HC Zeta HLC VM CC VM LC | 2007 |
| Resin Filling Material CoatingEBD · Class 2 | — | Maker | Akzent LCVITA ENAMIC Stains | 2013 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | CAD TempVITA Vionic Dent Disc Resin | 2007 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | VITA VIONIC BONDVITA VIONIC® BASE RESIN IMPACT | 2021 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | VITA VIONIC VIGOVITAPAN, VITAPAN PLUS, VITAPAN EXCELL, VITAPAN CUSPIFORM | 2007 |
| Silicate ProtectorEFX · Class 1 | — | Maker | VITAFol H | 2008 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | CAD WaxxVITA VIONIC WAX | 2006 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | VITA ENAMIC Polishing Set VITA SUPRINITY® Polishers | 2013 |
| Porcelain TeethELL · Class 2 | Dental ceramics & zirconia | Maker | Alumina Blanks Spinell Blanks Spinell Optimizer Alumina Optimizer In-Ceram Zirconia | 2007 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | VMLC Primer | 2026 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | VITA ENAMIC® Implant Solutions (IS) | 2017 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | Powder Scan Spray | 2013 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Lister | VITA VIONIC® DENT RESIN | 2025 |
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 Vita Zahnfabrik H. Rauter GmbH & Co. Kg. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Feb 2026 | K251587 | VITA VMLC Primer | KLE Resin Tooth Bonding Agent |
| 21 Feb 2025 | K243940 | VITA YZ Multi Translucent | EIH Porcelain Powder |
| 30 Dec 2015 | K152373 | VITA VM LC Flow | EBF Resin Tooth Shade Material |
| 31 Jan 2014 | K132070 | VITA SUPRINITY(R) | EIH Porcelain Powder |
| 13 Dec 2012 | K122269 | ENAMIC | EIH Porcelain Powder |
| 11 Aug 2010 | K102128 | VITABLOCS | EIH Porcelain Powder |
| 3 Dec 2009 | K093446 | VITA VMK MASTER | EIH Porcelain Powder |
| 31 Mar 2009 | K090644 | VITABLOCS, MODEL VX55-**** | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Amann Girrbach AG (3), pritidenta GmbH (1), Dentsply Sirona, Inc. (1), Institut Straumann AG (1).
Also lists devices cleared under other names
Vita Zahnfabrik H. Rauter GmbH & Co. Kg. 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: Vident (18), Vita Zahnfabrik GmbH H Rauter & CO (3), Zirkonzahn Srl (2), Vita Zahnfabrik H.Rauter GmbH Co. (2), Detax GmbH (1), Detax GmbH & Co. KG (1), Vita Zanhnfabrik H. Rauter GmbH Co. (1), Innovation Meditech GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Sep 2022 | K222877 | FREEPRINT crown | Detax GmbH | EBF Resin Tooth Shade Material |
| 22 Nov 2021 | K211854 | VITA Akzent LC | Vita Zahnfabrik GmbH H Rauter & CO | EBD Resin Filling Material Coating |
| 16 Nov 2020 | K200461 | Freeprint denture | Detax GmbH & Co. KG | EBI Rebasing Repairing Relining Denture Resin |
| 21 Jul 2020 | K193434 | VITA LUMEX AC | Vita Zahnfabrik GmbH H Rauter & CO | EIH Porcelain Powder |
| 14 May 2020 | K193436 | VITA Ambria | Vita Zahnfabrik GmbH H Rauter & CO | EIH Porcelain Powder |
| 29 Jan 2020 | K191926 | VITA VIONIC Bond | Vita Zanhnfabrik H. Rauter GmbH Co. | EBI Rebasing Repairing Relining Denture Resin |
| 22 Nov 2019 | K190518 | Color Liquid, Vita Liquid | Zirkonzahn Srl | EIH Porcelain Powder |
| 1 Aug 2018 | K180703 | VITA YZ ST and VITA YZ XT | Vita Zahnfabrik H.Rauter GmbH Co. | EIH Porcelain Powder |
| 30 Jun 2016 | K153645 | VITA ENAMIC Implant Solutions (IS) | Vita Zahnfabrik H.Rauter GmbH Co. | NHA Endosseous Dental Implant Abutment |
| 1 Mar 2013 | K123761 | VITA ENAMIC STAINS | Innovation Meditech GmbH | EBD Resin Filling Material Coating |
| 1 Jun 2007 | K070991 | VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 | Vita | EBG Resin Temporary Crown and Bridge |
| 29 Sep 2006 | K061851 | ZIRKONZAHN ICE | Zirkonzahn Srl | EIH Porcelain Powder |
| 27 Apr 2006 | K060441 | VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98 | Vident | EIH Porcelain Powder |
| 15 Aug 2005 | K052130 | VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 | Vident | EIH Porcelain Powder |
| 15 Mar 2005 | K050362 | VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) | Vident | EIH Porcelain Powder |
| 9 Oct 2002 | K022996 | VITA IN-CERAM YZ CUBES FOR CEREC | Vident | EIH Porcelain Powder |
| 17 May 2000 | K000597 | VITA RESPONSE | Vident | EIH Porcelain Powder |
| 9 Mar 1999 | K990108 | LC FLOWFILL | S & C Polymer GmbH | EBF Resin Tooth Shade Material |
| 2 Aug 1998 | K982664 | VITA TITANIUM PORCELAIN | Vident | EIH Porcelain Powder |
| 8 Jul 1996 | K961434 | VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM | Vident | EBF Resin Tooth Shade Material |
| 15 Mar 1996 | K960480 | IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 | Vident | ELL Porcelain Teeth |
| 2 May 1995 | K951183 | IN-CERAM SPINELL | Vident | EIH Porcelain Powder |
| 18 Mar 1994 | K934195 | VITA CELAY BLANKS AND VITA CELAY OPTIMIZER | Vident | EIH Porcelain Powder |
| 2 Jul 1992 | K921623 | VITADUR ALPHA PORCELAIN | Vident | EIH Porcelain Powder |
| 22 Jun 1992 | K913644 | VITA IN-CERAM | Vident | EIH Porcelain Powder |
| 18 Jun 1992 | K921474 | VITA OMEGA PORCELAIN | Vident | EIH Porcelain Powder |
| 2 Mar 1992 | K914476 | VITAPAN ACRYLIC DENTURE TEETH | Vident | ELM Teeth Plastic Denture |
| 10 Oct 1990 | K901862 | VMK 68 AND VMK 68N DENTAL PORCELAIN KIT | Vident | EIH Porcelain Powder |
| 5 Oct 1990 | K902200 | VITA HI-CERAM | Vident | EIH Porcelain Powder |
| 5 Oct 1990 | K901982 | VITACHROM-L DENTAL PORCELAIN KIT | Vident | EIH Porcelain Powder |
| 5 Oct 1990 | K902105 | VITADUR-N DENTAL PORCELAIN KIT | Vident | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.FDA reg. 1000625496 | BAD SACKINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9052908). 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.