The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Conquest Direct Filling Composite (dfc).
| Device ID | K904724 |
| 510k Number | K904724 |
| Device Name: | CONQUEST DIRECT FILLING COMPOSITE (DFC) |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Samuel Waknine |
| Correspondent | Samuel Waknine JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-17 |
| Decision Date | 1990-12-07 |