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 |