FDA 510(k)

G-BOND

K-Number: K041471 · 2004-06-29

Decision Date2004-06-29

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

G-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 2004-06-29 under 510(k) number K041471. 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 G-BOND?

G-BOND is a medical device that received FDA 510(k) clearance on 2004-06-29. The listed applicant is GC America, Inc.. The 510(k) number is K041471.

When did G-BOND receive FDA 510(k) clearance?

G-BOND received FDA 510(k) clearance on 2004-06-29, under 510(k) number K041471.

Who is the listed applicant for G-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 G-BOND?

The FDA product code for G-BOND is KLE.

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 Forte K253317Cytrans™ Elashield K261246SRGC-06 K254109G-CEM UNIVERSAL K251124G-Bond Universal K250953EQUIA LC ONE

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Related Devices (Code: KLE)

K262252MPa Max adhesiveDen-Mat Holdings, LLC 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.

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.