K911643 is an FDA 510(k) clearance for the ABIODENT PERIOTEMP(R) SYSTEM. This device is classified as a Gauge, Depth, Instrument, Dental (Class I - General Controls, product code EIL).
Submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on July 9, 1991, 88 days after receiving the submission on April 12, 1991.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K911643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1991 |
| Decision Date | July 09, 1991 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | EIL - Gauge, Depth, Instrument, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |