The following data is part of a premarket notification filed by Pentron Clinical Technologies with the FDA for Nano-bond Ii Adhesive System.
| Device ID | K071500 |
| 510k Number | K071500 |
| Device Name: | NANO-BOND II ADHESIVE SYSTEM |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | PENTRON CLINICAL TECHNOLOGIES 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson PENTRON CLINICAL TECHNOLOGIES 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-31 |
| Decision Date | 2007-08-10 |
| Summary: | summary |