K894058 is an FDA 510(k) clearance for the ISODENT. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Eurodent, Inc. (Canada J4b 5z5, CA). The FDA issued a Cleared decision on December 21, 1989, 197 days after receiving the submission on June 7, 1989.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K894058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1989 |
| Decision Date | December 21, 1989 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |