# K083766: Phoglass Cem

- Pathway: 510(k) (Traditional)
- Applicant: S & C Polymer GmbH
- Decided: Mar 2, 2009 after 74 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Fuji I (GC Corporation): named in the summary without a submission number

## Indications for use
PhoGlass Cem is intended to be used as an insoluble cement for cementing of crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands and used as a base or a liner.

Source page: https://510kreport.com/device/K083766
Methodology: https://510kreport.com/methodology