510(k) K222891
K222891 is an FDA 510(k) premarket notification submitted by Guangzhou Beogene Biotech Co., Ltd. for the device "Dental Desensitizer". The FDA issued a decision of Substantially Equivalent on May 25, 2023. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2023
- Date Received
- September 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type