# Nobel Biocare Services AG

- Location (FDA's records): Kloten, CH
- FDA decisions: 5 (2021–2023): 5 510(k) clearances
- Product codes: KCT (2), NHA (2), DZE (1)
- 510(k) review time since 2016: median 204 days, against 142 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 15 (2 its own); citations of its devices by later devices: 5 (2 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nobel Biocare AB: 13 (https://510kreport.com/company/nobel-biocare)

## Firms that cite its devices most
- Nobel Biocare AB: 2 (https://510kreport.com/company/nobel-biocare)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)

## Its most-cited devices
- K212932: Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray (2021), cited by 2
- K211109: N1 TiUltra TCC Implant System (2021), cited by 2
- K220048: NobelProcera Zirconia N1 Base (2022), cited by 1

## Recent decisions
- K231219: NobelZygoma PureSet™ Tray (Jun 27, 2023)
- K220339: Esthetic Abutments Nobel Biocare N1 (Sep 16, 2022)
- K220048: NobelProcera Zirconia N1 Base (Jul 29, 2022)
- K211109: N1 TiUltra TCC Implant System (Dec 21, 2021)
- K212932: Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray (Dec 18, 2021)

Source page: https://510kreport.com/company/nobel-biocare-services