# K071919: P.004 Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA (On Behalf of Institut Straumann Ag)
- Decided: Sep 26, 2007 after 76 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: 6 generations back to K894844 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 1.
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.
- K894844: Bonefit Implant System Accessories & Instruments, Straumann Institute, Ltd. (1990) Summary page 1.

## Indications for use
Both the P.004 RCINC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

Source page: https://510kreport.com/device/K071919
Methodology: https://510kreport.com/methodology