The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Dental Matrix Band.
| Device ID | K822094 |
| 510k Number | K822094 |
| Device Name: | DENTAL MATRIX BAND |
| Classification | Instruments, Dental Hand |
| Applicant | DENTSPLY INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZN |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-16 |
| Decision Date | 1982-08-16 |