K812605 is an FDA 510(k) clearance for the FIBER OPTIC LIGHT SOURCE I. This device is classified as a Light, Fiber Optic, Dental (Class I - General Controls, product code EAY).
Submitted by Venture Technology, Inc. (Walker, US). The FDA issued a Cleared decision on October 2, 1981, 17 days after receiving the submission on September 15, 1981.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4620.
| 510(k) Number | K812605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 1981 |
| Decision Date | October 02, 1981 |
| Days to Decision | 17 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 |