# K193260: U-Cem Premium & MAZIC Cem

- Pathway: 510(k) (Traditional)
- Applicant: Vericom Co., Ltd.
- Decided: Aug 21, 2020 after 269 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 K082449 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082449: Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012, Bisco, Inc. (2008) Summary page 4.

## Indications for use
1. Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties 2. Luting resin crowns, bridges, inlays, onlays and veneers 3. Luting metal or non-metal/fiber posts 4. Luting orthodontic appliances 5. Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)

Source page: https://510kreport.com/device/K193260
Methodology: https://510kreport.com/methodology