The following data is part of a premarket notification filed by Kerr Dental Materials Center with the FDA for Opaker.
| Device ID | K955337 |
| 510k Number | K955337 |
| Device Name: | OPAKER |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KERR DENTAL MATERIALS CENTER 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Contact | Larry Wills |
| Correspondent | Larry Wills KERR DENTAL MATERIALS CENTER 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-21 |
| Decision Date | 1996-01-23 |