# K081702: Carboxylate Cem, Phosphate Cem

- Pathway: 510(k) (Traditional)
- Applicant: S & C Polymer GmbH
- Decided: Sep 5, 2008 after 80 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 K982913 (1998). 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)
- K993324: Carbocem Zinc Polycarboxylate Cement, Scientific Pharmaceuticals, Inc. (1999) Summary page 1.
- K982913: Zinfos Zinc Phosphate Cement, Scientific Pharmaceuticals, Inc. (1998) Summary page 1.

## Indications for use
Carboxylate Cem: For temporary or permanent cementation of crowns and bridges on non-vital teeth where retention is of primary concern. Also for use as a temporary filling material. Phosphate Cem: For permanent cementation of crowns and bridges on non-vital teeth where the use of conventional Zinc phosphate cements is judged appropriate.

Source page: https://510kreport.com/device/K081702
Methodology: https://510kreport.com/methodology