# K974828: Branemark System (R) Ebon (TM) Fixture

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Mar 24, 1998 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 K945398 (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)
- K945398: Branemark System (R) Mkii Self-Tapping Fixture, Nobelpharma USA, Inc. (1995) Summary page 1.

## Indications for use
Nobel Biocare’s Ebon™ Fixtures are titanium endosseous implants that are intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth and to restore the patient’s chewing function. This fixture is not intended for use in type I bone.

Source page: https://510kreport.com/device/K974828
Methodology: https://510kreport.com/methodology