# K974123: Branemark System Dec 600 Drilling Unit

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: May 26, 1998 after 204 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 K905436 (1991). 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)
- K905436: Nobelpharma Drilling Equipment Dec 500, Nobelpharma USA, Inc. (1991) Summary page 1.

## Indications for use
The Nobel Biocare’s Branemark System® DEC 600 Drilling Unit is intended to be used in oral and maxillo facial surgery including placement of the Branemark System endosseous implants. It is intended to be used to drill into the upper or lower jaw to prepare placement of an endosseous fixture, in the treading and mounting of fixtures, while drilling measure and record torque resistance for bone quality, as well as to tighten cover and abutment screws.

Source page: https://510kreport.com/device/K974123
Methodology: https://510kreport.com/methodology