The following data is part of a premarket notification filed by Vident with the FDA for Vident Impac Implant Accessories.
Device ID | K904391 |
510k Number | K904391 |
Device Name: | VIDENT IMPAC IMPLANT ACCESSORIES |
Classification | Implant, Endosseous, Root-form |
Applicant | VIDENT 5130 COMMERCE DR. Baldwin Park, CA 91706 |
Contact | Ray Marrow |
Correspondent | Ray Marrow 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 | 1990-09-25 |
Decision Date | 1991-12-09 |