K803155 is an FDA 510(k) clearance for the PROPHYLAXIS CUP.. This device is classified as a Cup, Prophylaxis (Class I - General Controls, product code EHK).
Submitted by Teledyne Densco (Mchenry, US). The FDA issued a Cleared decision on January 8, 1981, 27 days after receiving the submission on December 12, 1980.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6290.
| 510(k) Number | K803155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1980 |
| Decision Date | January 08, 1981 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EHK — Cup, Prophylaxis |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6290 |