# K954030: Bone-Lock

- Pathway: 510(k) (Traditional)
- Applicant: Leibinger GmbH
- Decided: Nov 14, 1997 after 809 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Steri-Oss Threaded Titanium Implants: named in the summary without a submission number
- (no number) Bud Dental Implants: named in the summary without a submission number
- (no number) Nobelpharma/Branemark Dental Implants: named in the summary without a submission number

## Indications for use
Bone-Lock implants may be used for every indication generally prescribed for dental implants; in fact, the design and materials of the Bone-Lock implants were chosen, after extensive study, for successful use in even the most difficult patients, such as tumor patients with grafted and/or irradiated bone.

Source page: https://510kreport.com/device/K954030
Methodology: https://510kreport.com/methodology