The following data is part of a premarket notification filed by Moyco Industries, Inc. with the FDA for Colored Wedge Used To Separate Teeth.
| Device ID | K821444 |
| 510k Number | K821444 |
| Device Name: | COLORED WEDGE USED TO SEPARATE TEETH |
| Classification | Instruments, Dental Hand |
| Applicant | MOYCO INDUSTRIES, INC. 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 | 1982-05-14 |
| Decision Date | 1982-06-14 |