Helioseal F Plus
FDA 510(k) K190339 · Ivoclar Vivadent, AG
510(k) numberK190339
Submission
- Device name
- Helioseal F Plus
- Applicant
- Ivoclar Vivadent, AG
Schaan, LI - Received
- February 14, 2019
- Decision date
- July 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Helioseal F Plus cleared by the FDA?
Helioseal F Plus (K190339) received a 510(k) decision of Substantially Equivalent on July 29, 2019, 165 days after the submission was received.
What is the product code of K190339?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.