The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Dentsply Sirona Universal Spray Glazes.
| Device ID | K202629 |
| 510k Number | K202629 |
| Device Name: | Dentsply Sirona Universal Spray Glazes |
| Classification | Powder, Porcelain |
| Applicant | Dentsply Sirona 221 West Philadelphia Street, Suite 60 York, PA 17404 |
| Contact | Karl Nittinger |
| Correspondent | Karl Nittinger Dentsply Sirona 221 West Philadelphia Street, Suite 60 York, PA 17404 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-11 |
| Decision Date | 2021-01-20 |