# K960639: Abutment Selection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Nobelpharma USA, Inc.
- Decided: May 14, 1996 after 90 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 K944963 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944963: Branemark System Smiline II, Nobelpharma USA, Inc. (1995) Summary page 1.

## Indications for use
The Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit is intended to be used by practitioners to select the proper abutment.

Source page: https://510kreport.com/device/K960639
Methodology: https://510kreport.com/methodology