K982229 is an FDA 510(k) clearance for the BI-DENT. This device is classified as a Unit, Electrosurgical, And Accessories, Dental (Class II - Special Controls, product code EKZ).
Submitted by Valley Forge Scientific Corp. (Oaks, US). The FDA issued a Cleared decision on August 13, 1998, 90 days after receiving the submission on May 15, 1998.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4920.
| 510(k) Number | K982229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 1998 |
| Decision Date | August 13, 1998 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKZ — Unit, Electrosurgical, And Accessories, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4920 |