K833310 is an FDA 510(k) clearance for the FOGCUTTER DENTAL MOUTH MIRROR. This device is classified as a Mirror, Mouth (Class I - General Controls, product code EAX).
Submitted by Hti, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 7, 1984, 224 days after receiving the submission on September 26, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K833310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 1983 |
| Decision Date | May 07, 1984 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EAX — Mirror, Mouth |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |