The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat Tenure.
| Device ID | K872510 |
| 510k Number | K872510 |
| Device Name: | DEN-MAT TENURE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
| Contact | Robert L Ibsen |
| Correspondent | Robert L Ibsen DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-24 |
| Decision Date | 1987-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8131146B0 | K872510 | 000 |
| D8131145B0 | K872510 | 000 |
| D8130311460000 | K872510 | 000 |
| D8130301146100 | K872510 | 000 |
| D8130301145100 | K872510 | 000 |
| D8130398114010 | K872510 | 000 |