The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Tongue Holder/saliva Ejector.
| Device ID | K800210 |
| 510k Number | K800210 |
| Device Name: | TONGUE HOLDER/SALIVA EJECTOR |
| Classification | Mouthpiece, Saliva Ejector |
| Applicant | UNITEK CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYN |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-01 |
| Decision Date | 1980-02-06 |