The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Surefil One Self-adhesive Composite Hybrid.
| Device ID | K192530 |
| 510k Number | K192530 |
| Device Name: | Surefil One Self-adhesive Composite Hybrid |
| Classification | Cement, Dental |
| Applicant | Dentsply Sirona 221 W Philadelphia Street, Suite 60W York, PA 17401 |
| Contact | Karl Nittinger |
| Correspondent | Karl Nittinger Dentsply Sirona 221 W Philadelphia Street, Suite 60W York, PA 17401 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-16 |
| Decision Date | 2020-01-23 |