The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Dentin Conditioning And Adhesive System.
| Device ID | K936222 |
| 510k Number | K936222 |
| Device Name: | DENTIN CONDITIONING AND ADHESIVE SYSTEM |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Contact | Arun Prasad, Ph.d |
| Correspondent | Arun Prasad, Ph.d JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-29 |
| Decision Date | 1994-03-15 |