The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Dental Stain Remover.
| Device ID | K761352 |
| 510k Number | K761352 |
| Device Name: | DENTAL STAIN REMOVER |
| Classification | Toothbrush, Manual |
| Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-12-28 |
| Decision Date | 1977-01-03 |