The following data is part of a premarket notification filed by Vident with the FDA for Wide Body Abutments.
| Device ID | K984198 |
| 510k Number | K984198 |
| Device Name: | WIDE BODY ABUTMENTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
| Contact | Barbara J Lewandowski |
| Correspondent | Barbara J Lewandowski VIDENT 3150 EAST BIRCH ST. Brea, CA 92821 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-24 |
| Decision Date | 1999-02-18 |