510(k) K231338
K231338 is an FDA 510(k) premarket notification submitted by 3M Espe Dental Products for the device "3M Clinpro Clear 2.1% Sodium Fluoride Treatment". The FDA issued a decision of Substantially Equivalent on May 10, 2023. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. 3M Espe Dental Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2023
- Date Received
- May 8, 2023
- 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