The following data is part of a premarket notification filed by Pdc Management Services, Inc. with the FDA for Duo Dent.
| Device ID | K923694 |
| 510k Number | K923694 |
| Device Name: | DUO DENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | PDC MANAGEMENT SERVICES, INC. 340 BUTTERFIELD RD. Elmhurst, IL 60126 |
| Contact | James V D'alise |
| Correspondent | James V D'alise PDC MANAGEMENT SERVICES, INC. 340 BUTTERFIELD RD. Elmhurst, IL 60126 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-23 |
| Decision Date | 1994-05-18 |