# K132255: Ultracem

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products Inc. / Oratech, LLC
- Decided: Oct 24, 2013 after 97 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 K111855 (2011). 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)
- K111855: HY-Bond Resiglass, Shofu Dental Corp. (2011) Summary page 3.

## Indications for use
UltraCem™ is indicated for cementation of indirect restorations (Including inlays, onlays, crowns and bridges) made of metal, porcelain fused to metal, zirconia, and resin to natural teeth. This product is also intended for cementation of orthodontic bands to natural teeth.

Source page: https://510kreport.com/device/K132255
Methodology: https://510kreport.com/methodology