# K014175: Sulzer Dental Ceramic System-Hexlock

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Dental, Inc.
- Decided: Mar 20, 2002 after 90 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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 K953101 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953101: Paragon Implant System, Core-Vent Bio-Engineering, Inc. (1995) Summary page 1.
- K980630: Frialit-2 Corabase, Friatec AG (1998) Summary page 1.

## Indications for use
The intended use of the Sulzer Dental Ceramic System-HexLock is for anterior single unit restoration cases. This system is intended to improve esthetics in anterior cases by replacing the metal substructure within a restoration with a tooth color ceramic structure.

Source page: https://510kreport.com/device/K014175
Methodology: https://510kreport.com/methodology