K984641 is an FDA 510(k) clearance for the FLEXISCOPE OPTOMODUL. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Schoelly Fiberoptic GmbH (Newton, US). The FDA issued a Cleared decision on March 29, 1999, 88 days after receiving the submission on December 31, 1998.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K984641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 1998 |
| Decision Date | March 29, 1999 |
| Days to Decision | 88 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 |