The following data is part of a premarket notification filed by Dentsply Sirona Inc. with the FDA for Surgical Trays.
| Device ID | K212281 |
| 510k Number | K212281 |
| Device Name: | Surgical Trays |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Dentsply Sirona Inc. 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Contact | Courtney Clark |
| Correspondent | Courtney Clark Dentsply Sirona Inc. 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-21 |
| Decision Date | 2022-03-04 |