The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat Fiber Optic Halogen Light.
| Device ID | K802716 |
| 510k Number | K802716 |
| Device Name: | DEN-MAT FIBER OPTIC HALOGEN LIGHT |
| Classification | Light, Fiber Optic, Dental |
| Applicant | DEN-MAT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EAY |
| CFR Regulation Number | 872.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-31 |
| Decision Date | 1980-11-12 |