# K053565: Tempbond Clear with Triclosan

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Feb 3, 2006 after 43 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kerr Corporation, TempBond Clear: named in the summary without a submission number

## Most influential descendants
- K141503: Denali 501CEMENT (2014), 0 descendants of its own
- K111017: Cleartemp (2011), 0 descendants of its own

## Indications for use
TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, transparent, resin-based cement with triclosan designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays, onlays and splints.

Source page: https://510kreport.com/device/K053565
Methodology: https://510kreport.com/methodology