K780198 is an FDA 510(k) clearance for the PROPHY CUPS, R&R. This device is classified as a Cup, Prophylaxis (Class I - General Controls, product code EHK).
Submitted by Ransom and Randolph (Mchenry, US). The FDA issued a Cleared decision on February 16, 1978, 9 days after receiving the submission on February 7, 1978.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6290.
| 510(k) Number | K780198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1978 |
| Decision Date | February 16, 1978 |
| Days to Decision | 9 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 |