The following data is part of a premarket notification filed by Vident with the FDA for Pdq And Pdq-ti Abutment.
Device ID | K990367 |
510k Number | K990367 |
Device Name: | PDQ AND PDQ-TI ABUTMENT |
Classification | Implant, Endosseous, Root-form |
Applicant | VIDENT 3150 EAST BIRCH ST. PO BOX 2340 Brea, CA 92822 -2340 |
Contact | Barbara J Lewandowski |
Correspondent | Barbara J Lewandowski VIDENT 3150 EAST BIRCH ST. PO BOX 2340 Brea, CA 92822 -2340 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-05 |
Decision Date | 1999-04-21 |