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FDA 510(k)

GC TION GINGIVAL PROTECTOR

K-Number: K043301 · 2005-01-25

ApplicantGC America, Inc.
Decision Date2005-01-25
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC TION GINGIVAL PROTECTOR 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 2005-01-25 under 510(k) number K043301. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC TION GINGIVAL PROTECTOR?

GC TION GINGIVAL PROTECTOR is a medical device that received FDA 510(k) clearance on 2005-01-25. The listed applicant is GC America, Inc.. The 510(k) number is K043301.

When did GC TION GINGIVAL PROTECTOR receive FDA 510(k) clearance?

GC TION GINGIVAL PROTECTOR received FDA 510(k) clearance on 2005-01-25, under 510(k) number K043301.

Who is the listed applicant for GC TION GINGIVAL PROTECTOR?

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 TION GINGIVAL PROTECTOR?

The FDA product code for GC TION GINGIVAL PROTECTOR is EIE.

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Other records listing GC America, Inc. as applicant

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Related Devices (Code: EIE)

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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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