Temp Bond Clear
by Kerr Dental Materials Center 510(k)
Active
510(k) K972844
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972844 | Date3 Oct 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EMA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
Temp Bond Clear is a dental cement used for restorative and cosmetic procedures. It is a resin-based, dual-curing material designed for the temporary cementation of provisional restorations.
This device is supplied for professional dental use and is regulated under FDA 510(k) clearance. It is intended for clinical settings and should be stored according to the manufacturer's specifications.
Other devices from Kerr Dental Materials Center
Questions
AI-generated answers, 24 Sep 2026
What is Temp Bond Clear used for?
Temp Bond Clear is a resin-based, dual-curing dental cement specifically intended for the temporary cementation of provisional restorations during restorative and cosmetic dental procedures.
Who is this product intended for?
This device is supplied exclusively for professional dental use and is intended for application within clinical settings by qualified dental practitioners.
How should Temp Bond Clear be stored?
The material should be stored according to the specific instructions provided by the manufacturer to ensure the stability and performance of the resin-based cement.
What is the regulatory status of this device?
Temp Bond Clear is regulated under FDA 510(k) clearance, which indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.