# K111017: Cleartemp

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Jun 6, 2011 after 55 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 K053565 (2006). 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)
- K053565: Tempbond Clear with Triclosan, Sybron Dental Specialties, Inc. (2006) Summary page 1.

## Indications for use
ClearTemp is a provisional cement used for luting of thin translucent veneer restorations.

Source page: https://510kreport.com/device/K111017
Methodology: https://510kreport.com/methodology