510(k) K813015
K813015 is an FDA 510(k) premarket notification submitted by Vivadent (Usa), Inc. for the device "HELIOSEAL". The FDA issued a decision of Substantially Equivalent on December 2, 1981. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Vivadent (Usa), Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1981
- Date Received
- October 27, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sealant, Pit And Fissure, And Conditioner
- Device Class
- Class II
- Regulation Number
- 872.3765
- Review Panel
- DE
- Submission Type