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FDA 510(k)

GC ORAL MOISTURIZING GEL

K-Number: K101346 · 2011-01-27

ApplicantGC America, Inc.
Decision Date2011-01-27
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

GC ORAL MOISTURIZING GEL 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 2011-01-27 under 510(k) number K101346. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC ORAL MOISTURIZING GEL?

GC ORAL MOISTURIZING GEL is a medical device that received FDA 510(k) clearance on 2011-01-27. The listed applicant is GC America, Inc.. The 510(k) number is K101346.

When did GC ORAL MOISTURIZING GEL receive FDA 510(k) clearance?

GC ORAL MOISTURIZING GEL received FDA 510(k) clearance on 2011-01-27, under 510(k) number K101346.

Who is the listed applicant for GC ORAL MOISTURIZING GEL?

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 ORAL MOISTURIZING GEL?

The FDA product code for GC ORAL MOISTURIZING GEL is LFD.

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Related Devices (Code: LFD)

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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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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