The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Halley Resin.
| Device ID | K190043 |
| 510k Number | K190043 |
| Device Name: | Halley Resin |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-09 |
| Decision Date | 2019-04-24 |