# K082115: Phoglass Fill, Core, Cem, Seal,  Prime and Phoglass Protect

- Pathway: 510(k) (Traditional)
- Applicant: S & C Polymer GmbH
- Decided: Jan 15, 2009 after 171 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 IXGP Extra: named in the summary without a submission number
- (no number) Fuji VII: named in the summary without a submission number
- (no number) GC Dentin Conditioner: named in the summary without a submission number
- (no number) GC Fuji Varnish: named in the summary without a submission number

## Indications for use
PhoGlass Fill is intended to be used as an insoluble filling cement for uniplanar fillings of class 1,III and V cavities, for primary tooth fillings, for linings of composite fillings and also for core build-ups. PhoGlass Core is intended to be used as an insoluble core build-up cement and for underlinings of composite fillings. PhoGlass Seal is intended to be used as an insoluble sealing cement for hypersensitivity prevention and control, for root surface protection, for fissure protection and for intermediate restorations of lesions. PhoGlass Prime is intended to be used as a conditioner for dentin and enamel to enhance the bond between the cements and the tooth structure. PhoGlass Protect is intended for protecting PhoGlass restorations from exposure to moisture.

Source page: https://510kreport.com/device/K082115
Methodology: https://510kreport.com/methodology