Helioseal F Plus
K-Number: K190339 · 2019-07-29
ApplicantIvoclar Vivadent, AG
Decision Date2019-07-29
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Helioseal F Plus is a medical device manufactured by Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-07-29 under approval number K190339. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Helioseal F Plus?
Helioseal F Plus is a medical device that received FDA 510(k) clearance on 2019-07-29. It is manufactured by Ivoclar Vivadent, AG. The 510(k) number is K190339.
When was Helioseal F Plus approved by the FDA?
Helioseal F Plus received FDA 510(k) clearance on 2019-07-29, under approval number K190339.
What company makes Helioseal F Plus?
Helioseal F Plus is manufactured by Ivoclar Vivadent, AG.
What is the FDA product code for Helioseal F Plus?
The FDA product code for Helioseal F Plus is EBC.
Other Devices by Ivoclar Vivadent, AG
Related Devices (Code: EBC)
K161580Premier SealantPremier Dental Company Products
K171330Nanova SealantNanova Biomaterials, Inc.
K162598HAPI SealBisco, Inc.
K172169Pulpdent (Activa) Pit and Fissure Sealant with MCPPulpdent Corporation
K190998BA Pit & Fissure SealantApex Dental Materials, Inc.
K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.