The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Xeno Adhesive With Activator.
| Device ID | K051463 |
| 510k Number | K051463 |
| Device Name: | XENO ADHESIVE WITH ACTIVATOR |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-06-03 |
| Decision Date | 2005-07-12 |
| Summary: | summary |