The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Self Etch Bonding Primer.
| Device ID | K003011 |
| 510k Number | K003011 |
| Device Name: | SELF ETCH BONDING PRIMER |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 -0724 |
| Contact | Anumarie Tenero |
| Correspondent | Anumarie Tenero JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL ROAD 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 | 2000-09-26 |
| Decision Date | 2000-11-28 |