K800210 is an FDA 510(k) clearance for the TONGUE HOLDER/SALIVA EJECTOR. This device is classified as a Mouthpiece, Saliva Ejector (Class I - General Controls, product code DYN).
Submitted by Unitek Corp. (Mchenry, US). The FDA issued a Cleared decision on February 6, 1980, 5 days after receiving the submission on February 1, 1980.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K800210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1980 |
| Decision Date | February 06, 1980 |
| Days to Decision | 5 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DYN — Mouthpiece, Saliva Ejector |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |