# K014214: Sulzer Dental Ceramic System-Spline

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Dental, Inc.
- Decided: Mar 19, 2002 after 88 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 K943180 (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)
- K943180: Integral IV Biointegrated Dental Implant System, Calcitek, Inc. (1995) Summary page 1.
- K980630: Frialit-2 Corabase, Friatec AG (1998) Summary page 1.

## Indications for use
The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-unit cement-retained restorations. This product should not be sed in the molars and should not be splinted together for multiple unit cases, partials or bridgework.

Source page: https://510kreport.com/device/K014214
Methodology: https://510kreport.com/methodology