K900631 is an FDA 510(k) clearance for the SALIVA ABSORBER - DENTAL. This device is classified as a Mouthpiece, Saliva Ejector (Class I - General Controls, product code DYN).
Submitted by Kab Gloves Unltd. (Berkley, US). The FDA issued a Cleared decision on April 4, 1990, 55 days after receiving the submission on February 8, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K900631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 1990 |
| Decision Date | April 04, 1990 |
| Days to Decision | 55 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 |