# Vita Zahnfabrik H.Rauter GmbH & Co.

- Location (FDA's records): Bad Sackingen, DE
- FDA decisions: 13 (2009–2026): 13 510(k) clearances
- Names in FDA's records: Vita Zahnfabrik H.Rauter GmbH & Co. (6); Vita Zahnfabrik GmbH H Rauter & CO (3); Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (2); Vita Zahnfabrik H.Rauter GmbH Co. (2)
- Product codes: EIH (9), KLE (1), EBF (1), NHA (1), EBD (1)
- 510(k) review time since 2016: median 174 days, against 147 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 16 (4 its own); citations of its devices by later devices: 10 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vident: 4 (https://510kreport.com/company/vident)
- Ivoclar Vivadent, Inc.: 2 (https://510kreport.com/company/ivoclar-vivadent)
- Kuraray America, Inc.: 1 (https://510kreport.com/company/kuraray-america)
- Kulzer, Inc.: 1 (https://510kreport.com/company/kulzer)
- Espe Dental AG: 1 (https://510kreport.com/company/espe-dental)
- Sirona Dental Systems GmbH: 1 (https://510kreport.com/company/sirona-dental-systems)
- 3M Espe Dental Products: 1 (https://510kreport.com/company/3m-espe-dental-products)
- Innovation Meditech GmbH: 1 (https://510kreport.com/company/innovation-meditech)

## Firms that cite its devices most
- Kulzer, Inc.: 3 (https://510kreport.com/company/kulzer)
- Dental Laboratory Milling Supplies, LLC (Dlms): 1 (https://510kreport.com/company/dental-laboratory-milling-supplies-dlms)
- Sirona Dental Systems GmbH: 1 (https://510kreport.com/company/sirona-dental-systems)
- Zirkonzahn Srl: 1 (https://510kreport.com/company/zirkonzahn)

## Its most-cited devices
- K122269: Enamic (2012), cited by 3
- K152373: VITA VM LC Flow (2015), cited by 2
- K180703: VITA YZ ST and VITA YZ XT (2018), cited by 2
- K102128: Vitablocs (2010), cited by 1
- K090644: Vitablocs, Model VX55-**** (2009), cited by 1
- K211854: VITA Akzent LC (2021), cited by 1

## Recent decisions
- K251587: VITA VMLC Primer (Feb 23, 2026)
- K243940: VITA YZ Multi Translucent (Feb 21, 2025)
- K211854: VITA Akzent LC (Nov 22, 2021)
- K193434: Vita Lumex AC (Jul 21, 2020)
- K193436: VITA Ambria (May 14, 2020)
- K180703: VITA YZ ST and VITA YZ XT (Aug 1, 2018)
- K153645: VITA ENAMIC Implant Solutions (IS) (Jun 30, 2016)
- K152373: VITA VM LC Flow (Dec 30, 2015)

Source page: https://510kreport.com/company/vita-zahnfabrik-h-rauter