FDA 510(k)

GCUC-505

K-Number: K091388 · 2009-07-22

Decision Date2009-07-22

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GCUC-505 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 2009-07-22 under 510(k) number K091388. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GCUC-505?

GCUC-505 is a medical device that received FDA 510(k) clearance on 2009-07-22. The listed applicant is GC America, Inc.. The 510(k) number is K091388.

When did GCUC-505 receive FDA 510(k) clearance?

GCUC-505 received FDA 510(k) clearance on 2009-07-22, under 510(k) number K091388.

Who is the listed applicant for GCUC-505?

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 GCUC-505?

The FDA product code for GCUC-505 is EBF.

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.

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Related Devices (Code: EBF)

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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.