K831824 is an FDA 510(k) clearance for the DENTAL ELECTRONIC/S.B.R TRADING BU HAND. This device is classified as a Light, Fiber Optic, Dental (Class I - General Controls, product code EAY).
Submitted by Silverman'S (Mchenry, US). The FDA issued a Cleared decision on August 11, 1983, 65 days after receiving the submission on June 7, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4620.
| 510(k) Number | K831824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1983 |
| Decision Date | August 11, 1983 |
| Days to Decision | 65 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 |