The following data is part of a premarket notification filed by Dentec, Inc. with the FDA for Peri Mirror/saliva Ejector.
| Device ID | K833429 |
| 510k Number | K833429 |
| Device Name: | PERI MIRROR/SALIVA EJECTOR |
| Classification | Mirror, Mouth |
| Applicant | DENTEC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EAX |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-05 |
| Decision Date | 1983-12-22 |