# Nobel Biocare Uas, Inc.

- Location (FDA's records): Yorba Linda,, CA
- FDA decisions: 31 (1997–2005): 31 510(k) clearances
- Product codes: DZE (20), NHA (8), EIH (2), DZI (1)
- Predicates its devices cite: 71 (15 its own); citations of its devices by later devices: 115 (15 its own)
- Recalls linked to its devices: 45 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nobelpharma USA, Inc.: 33 (https://510kreport.com/company/nobelpharma-usa)
- Nobel Biocare AB: 4 (https://510kreport.com/company/nobel-biocare)
- Steri-Oss, Inc.: 4 (https://510kreport.com/company/steri-oss)
- Straumann USA: 3 (https://510kreport.com/company/straumann-usa)
- Sargon Ent., Inc.: 2 (https://510kreport.com/company/sargon-ent)
- Ceramic Core Corp.: 2 (https://510kreport.com/company/ceramic-core)
- Ace Surgical Supply Co., Inc.: 1 (https://510kreport.com/company/ace-surgical-supply)
- Vident: 1 (https://510kreport.com/company/vident)

## Firms that cite its devices most
- Nobel Biocare AB: 17 (https://510kreport.com/company/nobel-biocare)
- Cowellmedi Co., Ltd.: 5 (https://510kreport.com/company/cowellmedi)
- Implant Innovations, Inc.: 4 (https://510kreport.com/company/implant-innovations)
- Inclusive Dental Solutions: 4 (https://510kreport.com/company/inclusive-dental-solutions)
- Sulzer Dental, Inc.: 4 (https://510kreport.com/company/sulzer-dental)
- Atlantis Components, Inc.: 4 (https://510kreport.com/company/atlantis-components)
- Southern Implants (Pty), Ltd.: 3 (https://510kreport.com/company/southern-implants)
- Megagen Co., Ltd.: 2 (https://510kreport.com/company/megagen)

## Its most-cited devices
- K023113: Replace Tiunite Endosseous Implant (2002), cited by 17
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 (2004), cited by 10
- K041661: Nobel Biocare Endosseous Implants (2004), cited by 8
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement) (2000), cited by 7
- K992937: Dental Implant (2000), cited by 7
- K023952: Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite (2003), cited by 6

## Recent decisions
- K050444: Nobelreplace Adapter, Model 32412 (Jul 7, 2005)
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 (Oct 20, 2004)
- K041661: Nobel Biocare Endosseous Implants (Aug 26, 2004)
- K041876: Nobeldirect OD Implant (Aug 20, 2004)
- K041312: Nobelrondo Dental Ceramic-Alumina (Jul 23, 2004)
- K041275: Procera Abutment Octagon (May 27, 2004)
- K040573: Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236 (Apr 28, 2004)
- K033724: Nobel Biocare Centric Post, Models 31234, 31235 and 31236 (Feb 23, 2004)

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