# K041275: Procera Abutment Octagon

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: May 27, 2004 after 15 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K894844 (1990). 27 ancestors in all.
61 later devices descend from it; 3 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031719: Esthetic Zirconia Abutment, Nobel Biocare AB (2003)
- K971706: Tiadapt Abutment System, Nobel Biocare Uas, Inc. (1997) Summary page 1.
- K033243: Iti Synocta Meso Abutments, Straumann USA (2003) Summary page 1.

## Most influential descendants
- K061478: Procera Titanium Abutment for Astratech and Camlog Implant Systems (2006), 33 descendants of its own
- K103252: Camlog Vario SR Abutments (2011), 32 descendants of its own
- K061529: Procera Zirconia Abutment for Camlog Implant System (2006), 26 descendants of its own
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K121334: Varioeco (2012), 16 descendants of its own

## Indications for use
Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous patients requiring prosthetic devices that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.

Source page: https://510kreport.com/device/K041275
Methodology: https://510kreport.com/methodology