The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Prime&bond Active Universal Adhesive.
| Device ID | K181476 |
| 510k Number | K181476 |
| Device Name: | Prime&Bond Active Universal Adhesive |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Contact | Karl Nittinger |
| Correspondent | Karl Nittinger Dentsply Sirona 221 West Philadelphia Street, Suite 60W 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 | 2018-06-05 |
| Decision Date | 2018-09-28 |
| Summary: | summary |