# K041136: Modification to Silhouette IC or Silhouette; Laser-Lok Surface Treatment -Optional Surface Modification to Implants

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Lok Intl., Inc.
- Decided: Oct 22, 2004 after 175 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 K032454 (2004). 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)
- K032454: Silhouette (TM) IC or Silhouette (TM) & Laser-Lok (TM), Bio-Lok Intl., Inc. (2004) Summary page 1.

## Indications for use
The implant is designed for use in edentulous sites for support of 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/K041136
Methodology: https://510kreport.com/methodology