510(k) K220419
K220419 is an FDA 510(k) premarket notification submitted by Sangi Co., Ltd. for the device "Apapro Desensitizer". The FDA issued a decision of Substantially Equivalent on February 16, 2022. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Sangi Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2022
- Date Received
- February 14, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type