# K032454: Silhouette (TM) IC or Silhouette (TM) & Laser-Lok (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Lok Intl., Inc.
- Decided: Mar 4, 2004 after 206 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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) Micro-Lok implants: named in the summary without a submission number
- (no number) Astra Tech Fixture ST: named in the summary without a submission number
- (no number) Osseotite NT: named in the summary without a submission number
- (no number) Frialit-2: named in the summary without a submission number

## Most influential descendants
- K050956: TBR Idea Conic/Conic (2006), 2 descendants of its own
- K073622: Easy Grip Dental Implant System (2008), 0 descendants of its own
- K070935: T.B.R. Zirconnect (2007), 0 descendants of its own
- K041136: Modification to Silhouette IC or Silhouette; Laser-Lok Surface Treatment -Optional Surface Modification to Implants (2004), 0 descendants of its own

## 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/K032454
Methodology: https://510kreport.com/methodology