510(k) K191453
K191453 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, AG for the device "Cervitec F". The FDA issued a decision of Substantially Equivalent on February 11, 2020. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Ivoclar Vivadent, AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2020
- Date Received
- May 31, 2019
- 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