The following data is part of a premarket notification filed by Pentron Clinical Technologies with the FDA for Generation 8 Se Adhesive.
| Device ID | K072480 |
| 510k Number | K072480 |
| Device Name: | GENERATION 8 SE ADHESIVE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | PENTRON CLINICAL TECHNOLOGIES 68-70 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 |
| Contact | Greg Marceau |
| Correspondent | Greg Marceau PENTRON CLINICAL TECHNOLOGIES 68-70 NORTH PLAINS INDUSTRIAL ROAD 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 | 2007-09-04 |
| Decision Date | 2007-11-21 |
| Summary: | summary |