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FDA 510(k)

Premier Sealant

K-Number: K161580 · 2016-10-18

ApplicantPremier Dental Company Products
Decision Date2016-10-18
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Premier Sealant is a medical device manufactured by Premier Dental Company Products. It received FDA 510(k) clearance on 2016-10-18 under approval number K161580. 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 Premier Sealant?

Premier Sealant is a medical device that received FDA 510(k) clearance on 2016-10-18. It is manufactured by Premier Dental Company Products. The 510(k) number is K161580.

When was Premier Sealant approved by the FDA?

Premier Sealant received FDA 510(k) clearance on 2016-10-18, under approval number K161580.

What company makes Premier Sealant?

Premier Sealant is manufactured by Premier Dental Company Products.

What is the FDA product code for Premier Sealant?

The FDA product code for Premier Sealant is EBC.

Other Devices by Premier Dental Company Products

K180682AeroPro Cordless Prophy System

Related Devices (Code: EBC)

K171330Nanova SealantNanova Biomaterials, Inc. K162598HAPI SealBisco, Inc. K172169Pulpdent (Activa) Pit and Fissure Sealant with MCPPulpdent Corporation K190998BA Pit & Fissure SealantApex Dental Materials, Inc. K190339Helioseal F PlusIvoclar Vivadent, AG 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.

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