# K081818: Biolok Micro-Lok Implant System

- Pathway: 510(k) (Special)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Nov 13, 2008 after 139 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 K952905 (1997). 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)
- K952905: Minimatic Various Implant Systems, Minimatic, Inc. (1997) Summary page 1.

## Indications for use
The BioLok Micro-Lok Implant System may be used in edentulous sites for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.

Source page: https://510kreport.com/device/K081818
Methodology: https://510kreport.com/methodology