K000967 is an FDA 510(k) clearance for the 4635 ASSISTANT'S INSTRUMENTATION. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on May 3, 2000, 37 days after receiving the submission on March 27, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K000967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2000 |
| Decision Date | May 03, 2000 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |