# K122549: Dento Temp

- Pathway: 510(k) (Abbreviated)
- Applicant: Itena Clinical
- Decided: Apr 26, 2013 after 248 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 K033309 (2004). 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)
- K033309: Premier Implant Cement, Model 3001450, Premier Dental Products Co. (2004) Summary page 1.

## Indications for use
It is intended for: 1) quick temporary cementation of temporary crowns and bridges; 2) rebasing of crowns; and 3) permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired. DentoTemp is fully compatible with both acrylic and composite (bis-acryl) temporary materials and as a result, is indicated on both natural and metal implants abutments.

Source page: https://510kreport.com/device/K122549
Methodology: https://510kreport.com/methodology