The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Optibond All-in-one.
| Device ID | K060469 |
| 510k Number | K060469 |
| Device Name: | OPTIBOND ALL-IN-ONE |
| Classification | Agent, Tooth Bonding, Resin |
| 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-02-23 |
| Decision Date | 2006-03-28 |
| Summary: | summary |