The following data is part of a premarket notification filed by Vident with the FDA for Impac Torque Wrench.
| Device ID | K940998 |
| 510k Number | K940998 |
| Device Name: | IMPAC TORQUE WRENCH |
| Classification | Implant, Endosseous, Root-form |
| Applicant | VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
| Contact | Ray E Morrow |
| Correspondent | Ray E Morrow VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-04 |
| Decision Date | 1994-11-21 |