510(k) K233768
K233768 is an FDA 510(k) premarket notification submitted by Elevate Oral Care for the device "Papacarie Duo". The FDA issued a decision of Substantially Equivalent on July 18, 2024. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Elevate Oral Care has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2024
- Date Received
- November 24, 2023
- 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