The following data is part of a premarket notification filed by Pentron Clinical with the FDA for B1p Adhesive.
| Device ID | K111431 |
| 510k Number | K111431 |
| Device Name: | B1P ADHESIVE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | PENTRON CLINICAL 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman PENTRON CLINICAL 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-23 |
| Decision Date | 2011-08-01 |
| Summary: | summary |