K780864 is an FDA 510(k) clearance for the DIAMOND STONES. This device is classified as a Instrument, Diamond, Dental (Class I - General Controls, product code DZP).
Submitted by Venture Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1978, 15 days after receiving the submission on May 30, 1978.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4535.
| 510(k) Number | K780864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1978 |
| Decision Date | June 14, 1978 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DZP — Instrument, Diamond, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4535 |