The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Tempbond Clear With Triclosan.
| Device ID | K053565 |
| 510k Number | K053565 |
| Device Name: | TEMPBOND CLEAR WITH TRICLOSAN |
| Classification | Cement, Dental |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 100 BAYVIEW CIRCLE, SUITE 6000 Newport Beach, CA 92660 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 100 BAYVIEW CIRCLE, SUITE 6000 Newport Beach, CA 92660 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-12-22 |
| Decision Date | 2006-02-03 |
| Summary: | summary |