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FDA 510(k)

GC XLC-100 CAPSULE

K-Number: K061535 · 2006-07-14

ApplicantGC America, Inc.
Decision Date2006-07-14
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC XLC-100 CAPSULE 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 2006-07-14 under 510(k) number K061535. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC XLC-100 CAPSULE?

GC XLC-100 CAPSULE is a medical device that received FDA 510(k) clearance on 2006-07-14. The listed applicant is GC America, Inc.. The 510(k) number is K061535.

When did GC XLC-100 CAPSULE receive FDA 510(k) clearance?

GC XLC-100 CAPSULE received FDA 510(k) clearance on 2006-07-14, under 510(k) number K061535.

Who is the listed applicant for GC XLC-100 CAPSULE?

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 XLC-100 CAPSULE?

The FDA product code for GC XLC-100 CAPSULE is EMA.

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Other records listing GC America, Inc. as applicant

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Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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.

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