K831976 is an FDA 510(k) clearance for the POWER OPTIC. This device is classified as a Light, Fiber Optic, Dental (Class I - General Controls, product code EAY).
Submitted by Ritter Co. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983, 53 days after receiving the submission on June 20, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4620.
| 510(k) Number | K831976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 1983 |
| Decision Date | August 12, 1983 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EAY — Light, Fiber Optic, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4620 |