# K970499: Branemark System Zygomaticus Fixture System

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Oct 16, 1997 after 248 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 K925771 (1993). 8 ancestors in all.
50 later devices descend from it; 5 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925762: Branemark System Self-Tapping Fixture, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925770: Branemark System Drills and Countersinks, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925775: Branemark System Machine Inst. Acc. to Drilling EQ, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925771: Branemark System Titanium Cover Screws, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925774: Branemark System Hand Instrument, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925483: Branemark Syst. Hand Inst. Dia 297 & Sdia 276, Nobelpharma USA, Inc. (1994) Summary page 1.
- K953774: Branemark Restorative Instrument & Component Tray, Nobelpharma USA, Inc. (1995) Summary page 1.
- K951510: Ace Bone Screw Tacking Kit, Ace Surgical Supply Co., Inc. (1995) Summary page 1.

## Most influential descendants
- K033171: Nsi Hexed and Non-Hexed Implant System and Immediate Loading (2004), 32 descendants of its own
- K052490: Endosseous Dental Implant System (2005), 31 descendants of its own
- K061169: Endosseous Dental Implant (2006), 24 descendants of its own
- K070841: Endosseous Dental Implant System (2007), 21 descendants of its own
- K070182: Zygoma Implant (Immediate Function) (2007), 19 descendants of its own

## Indications for use
The Nobel Biocare Brinemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanjum intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient’s chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.

Source page: https://510kreport.com/device/K970499
Methodology: https://510kreport.com/methodology