FDA 510(k)

HC Primer

K-Number: K161891 · 2016-11-21

Decision Date2016-11-21

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

HC Primer is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K161891. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HC Primer?

HC Primer is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Shofu Dental Corporation. The 510(k) number is K161891.

When did HC Primer receive FDA 510(k) clearance?

HC Primer received FDA 510(k) clearance on 2016-11-21, under 510(k) number K161891.

Who is the listed applicant for HC Primer?

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

What is the FDA product code for HC Primer?

The FDA product code for HC Primer is KLE.

Other records listing Shofu Dental Corporation 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.

K252808GlasIonomer FX-LC K252165ZIRCONOMER P K251470ResiCem EX K251578BEAUTIFIL II K233161BeautiLink SA K222253GlasIonomer FX ULTRA

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Related Devices (Code: KLE)

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products Company K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental 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.