The following data is part of a premarket notification filed by Dentsply International Inc. with the FDA for Prime&bond Elect Universal Dental Adhesive.
| Device ID | K151619 |
| 510k Number | K151619 |
| Device Name: | Prime&Bond Elect Universal Dental Adhesive |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-16 |
| Decision Date | 2015-10-30 |
| Summary: | summary |