K801974 is an FDA 510(k) clearance for the ANALYTIC TECH. METAL POINT HEATER #3001. This device is classified as a Instrument, Hand, Calculus Removal (Class I - General Controls, product code ELA).
Submitted by Analytic Technology (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980, 85 days after receiving the submission on August 19, 1980.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K801974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1980 |
| Decision Date | November 12, 1980 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ELA — Instrument, Hand, Calculus Removal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |