# Nobel Biocare AB

- Location (FDA's records): Yorba Linda,, CA
- FDA decisions: 96 (2002–2026): 96 510(k) clearances
- Names in FDA's records: Nobel Biocare AB (94); Nobel Biocare AG (2)
- Product codes: NHA (43), DZE (31), LLZ (8), ELL (5), KCT (4), FZE (1), PNP (1), EBI (1), MYN (1), EIH (1)
- 510(k) review time since 2016: median 175 days, against 188 for FDA's reviews in the same codes and years (20 of 40 faster)
- Predicates its devices cite: 173 (101 its own); citations of its devices by later devices: 300 (101 its own)
- Recalls linked to its devices: 36 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nobel Biocare Uas, Inc.: 17 (https://510kreport.com/company/nobel-biocare-uas)
- Nobel Biocare USA, LLC: 9 (https://510kreport.com/company/nobel-biocare-usa)
- Nobelpharma USA, Inc.: 5 (https://510kreport.com/company/nobelpharma-usa)
- Altatec Biotechnologies N.A., Inc.: 3 (https://510kreport.com/company/altatec-biotechnologies-na)
- Astra Tech, Inc.: 3 (https://510kreport.com/company/astra-tech)
- Thommen Medical AG: 2 (https://510kreport.com/company/thommen-medical)
- Palodex Group OY: 2 (https://510kreport.com/company/palodex-group)
- Medicim NV: 2 (https://510kreport.com/company/medicim)

## Firms that cite its devices most
- Nobel Biocare Services AG: 13 (https://510kreport.com/company/nobel-biocare-services)
- Terrats Medical SL: 12 (https://510kreport.com/company/terrats-medical)
- A.B. Dental Devices, Ltd.: 9 (https://510kreport.com/company/ab-dental-devices)
- Dentsply International, Inc.: 6 (https://510kreport.com/company/dentsply-international)
- Nobel Biocare USA, LLC: 6 (https://510kreport.com/company/nobel-biocare-usa)
- Southern Implants (Pty), Ltd.: 6 (https://510kreport.com/company/southern-implants)
- Institut Straumann AG: 5 (https://510kreport.com/company/institut-straumann)
- Biodenta Swiss AG: 4 (https://510kreport.com/company/biodenta-swiss)

## Its most-cited devices
- K071370: Nobelactive Internal Connection Implant (2007), cited by 29
- K022562: Various Branemark System Implants-Immediate Function Indication (2002), cited by 19
- K072570: Nobelactive Multi Unit Abutment (2007), cited by 18
- K050406: Nobelspeedy Implants (2005), cited by 16
- K102436: Nobel Active 3.0 (2010), cited by 14
- K091756: Nobelprocera TI Abutment (2009), cited by 10

## Recent decisions
- K253988: LiteSet Trays (Sep 8, 2026)
- K253999: Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw (Aug 6, 2026)
- K252197: Nobel Biocare S Series Implants (Feb 18, 2026)
- K243834: NobelZygoma TiUltra Implant system (Aug 25, 2025)
- K240346: NobelProcera Zirconia Implant Bridge (Jan 3, 2025)
- K233208: NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium (Jan 24, 2024)
- K231898: DTX Studio Clinic (4.0) (Dec 8, 2023)
- K223677: Titanium Abutment Blank Nobel Biocare N1 TCC (Apr 28, 2023)

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