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FDA 510(k)

GC Acrylic Primer

K-Number: K180917 · 2018-11-20

ApplicantGC America, Inc.
Decision Date2018-11-20
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC Acrylic Primer is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2018-11-20 under 510(k) number K180917. 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 GC Acrylic Primer?

GC Acrylic Primer is a medical device that received FDA 510(k) clearance on 2018-11-20. The listed applicant is GC America, Inc.. The 510(k) number is K180917.

When did GC Acrylic Primer receive FDA 510(k) clearance?

GC Acrylic Primer received FDA 510(k) clearance on 2018-11-20, under 510(k) number K180917.

Who is the listed applicant for GC Acrylic Primer?

The FDA 510(k) record lists GC America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GC Acrylic Primer?

The FDA product code for GC Acrylic Primer is KLE.

Other records listing GC America, Inc. as applicant

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Related Devices (Code: KLE)

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.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA 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.

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