# K961737: Cera One Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Nobelpharma USA, Inc.
- Decided: Jul 10, 1996 after 68 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910611 (1991). 1 ancestor in all.
550 later devices descend from it; 3 cite it directly.
0 of 552 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910611: Nobelpharma Ceraone Abutment System, Nobelpharma USA, Inc. (1991) Summary page 1.

## Most influential descendants
- K962403: Noblepharma Wide Accessories (1996), 549 descendants of its own
- K971706: Tiadapt Abutment System (1997), 545 descendants of its own
- K974150: Procera Preparable Abutment System (1998), 543 descendants of its own
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar (2004), 476 descendants of its own
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 (2004), 441 descendants of its own

## Indications for use
The Nobelpharma CeraOne Abutment System is intended to be used to anchor single tooth prostheses in partially edentulous patients.

Source page: https://510kreport.com/device/K961737
Methodology: https://510kreport.com/methodology