The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Bond-it Dual Cure Activator.
| Device ID | K953859 |
| 510k Number | K953859 |
| Device Name: | BOND-IT DUAL CURE ACTIVATOR |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | JENERIC/PENTRON, INC. 125 N. PLAINS IND. RD. Wallingford, CT 06492 -0724 |
| Contact | Joseph Mac Dougal |
| Correspondent | Joseph Mac Dougal JENERIC/PENTRON, INC. 125 N. PLAINS IND. RD. 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 | 1995-08-17 |
| Decision Date | 1995-09-07 |