The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Rembrandt Shade Modification Kit.
| Device ID | K841111 |
| 510k Number | K841111 |
| Device Name: | REMBRANDT SHADE MODIFICATION KIT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DEN-MAT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-15 |
| Decision Date | 1984-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8130339099500 | K841111 | 000 |
| D8130339099000 | K841111 | 000 |
| D813030967101B0 | K841111 | 000 |