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FDA 510(k)

UNIFIL BOND

K-Number: K013997 · 2002-02-20

ApplicantGC America, Inc.
Decision Date2002-02-20
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNIFIL BOND 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 2002-02-20 under 510(k) number K013997. 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 UNIFIL BOND?

UNIFIL BOND is a medical device that received FDA 510(k) clearance on 2002-02-20. The listed applicant is GC America, Inc.. The 510(k) number is K013997.

When did UNIFIL BOND receive FDA 510(k) clearance?

UNIFIL BOND received FDA 510(k) clearance on 2002-02-20, under 510(k) number K013997.

Who is the listed applicant for UNIFIL BOND?

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 UNIFIL BOND?

The FDA product code for UNIFIL BOND is KLE.

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Other records listing GC America, Inc. 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.

K262202Cerasmart ForteK253317Cytrans™ ElashieldK261246SRGC-06K254109G-CEM UNIVERSALK251124G-Bond UniversalK250953EQUIA LC ONE

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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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-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.

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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