The following data is part of a premarket notification filed by Coltene, Inc. with the FDA for Coltene Drs Dental Restorative System.
| Device ID | K811363 |
| 510k Number | K811363 |
| Device Name: | COLTENE DRS DENTAL RESTORATIVE SYSTEM |
| Classification | Material, Tooth Shade, Resin |
| Applicant | COLTENE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-14 |
| Decision Date | 1981-06-16 |