The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Matrix Strip, Dead-soft.
| Device ID | K772316 |
| 510k Number | K772316 |
| Device Name: | MATRIX STRIP, DEAD-SOFT |
| Classification | Instruments, Dental Hand |
| Applicant | DEN-MAT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DZN |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-19 |
| Decision Date | 1978-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813CR00020 | K772316 | 000 |
| D8130310003000 | K772316 | 000 |