# K242366: OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Overfibers S.R.L.
- Decided: Jan 10, 2025 after 154 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: 13 generations back to K931812 (1993). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200798: G-Cem One, GC America, Inc. (2020) Summary page 5.

## Indications for use
1. Definitive cementation of inlays, onlays, crowns and bridges, in ceramic or zirconia, composite or metal; 2-3 unit Maryland bridges and 3-unit inlay/onlay bridges (to be avoided for patients with bruxism or periodontitis). 2. Definitive cementation of endocanal posts. 3. Definitive cementation of ceramic, zirconia, composite or metal restorations on implant abutments and natural teeth. 4. Definitive cementation of zirconium oxide superstructures for two-unit abutments

Source page: https://510kreport.com/device/K242366
Methodology: https://510kreport.com/methodology