K832179 is an FDA 510(k) clearance for the HOT PROBE MODEL 6001. This device is classified as a Heat Source For Bleaching Teeth (Class I - General Controls, product code EEG).
Submitted by Analytic Technology (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983, 90 days after receiving the submission on July 6, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6475.
| 510(k) Number | K832179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1983 |
| Decision Date | October 04, 1983 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EEG — Heat Source For Bleaching Teeth |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6475 |