510(k) K200614
K200614 is an FDA 510(k) premarket notification submitted by Largent Health, LLC for the device "FiteBac Antimicrobial Cavity Cleanser". The FDA issued a decision of Substantially Equivalent on June 25, 2020. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Largent Health, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2020
- Date Received
- March 9, 2020
- 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