The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Optibond 2a Precoat.
| Device ID | K955068 |
| 510k Number | K955068 |
| Device Name: | OPTIBOND 2A PRECOAT |
| Classification | Cement, Dental |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Contact | Jeffrey A Anderson |
| Correspondent | Jeffrey A Anderson SYBRON DENTAL SPECIALTIES, INC. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-06 |
| Decision Date | 1995-12-11 |