FDA 510(k)

BZF-29

K-Number: K200682 · 2020-10-02

Decision Date2020-10-02

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BZF-29 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 2020-10-02 under 510(k) number K200682. 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 BZF-29?

BZF-29 is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is GC America, Inc.. The 510(k) number is K200682.

When did BZF-29 receive FDA 510(k) clearance?

BZF-29 received FDA 510(k) clearance on 2020-10-02, under 510(k) number K200682.

Who is the listed applicant for BZF-29?

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 BZF-29?

The FDA product code for BZF-29 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.

K253317Cytrans™ Elashield K261246SRGC-06 K254109G-CEM UNIVERSAL K251124G-Bond Universal K250953EQUIA LC ONE K251946G aenial Universal Injectable II

View all 24 devices →

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.