The following data is part of a premarket notification filed by Valley Forge Scientific Corp. with the FDA for Bi-dent.
| Device ID | K982229 |
| 510k Number | K982229 |
| Device Name: | BI-DENT |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | VALLEY FORGE SCIENTIFIC CORP. 136 GREEN TREE RD. P.O. BOX 1179 Oaks, PA 19456 |
| Contact | Thomas J Gilloway |
| Correspondent | Thomas J Gilloway VALLEY FORGE SCIENTIFIC CORP. 136 GREEN TREE RD. P.O. BOX 1179 Oaks, PA 19456 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-15 |
| Decision Date | 1998-08-13 |
| Summary: | summary |