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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 the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Company Products. It received FDA 510(k) clearance on 2016-10-18 under 510(k) 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. The listed applicant is Premier Dental Company Products. The 510(k) number is K161580.

When did Premier Sealant receive FDA 510(k) clearance?

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

Who is the listed applicant for Premier Sealant?

The FDA 510(k) record lists Premier Dental Company Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Premier Sealant?

The FDA product code for Premier Sealant is EBC.

Other records listing Premier Dental Company Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180682AeroPro Cordless Prophy System

Related Devices (Code: EBC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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