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FDA 510(k)

GUMEASE DENTAL MOUTHPIECE

K-Number: K072082 · 2007-11-05

ApplicantBiomedevice , Ltd.
Decision Date2007-11-05
Product CodeKKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GUMEASE DENTAL MOUTHPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Biomedevice , Ltd.. It received FDA 510(k) clearance on 2007-11-05 under 510(k) number K072082. The device is classified under product code KKO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUMEASE DENTAL MOUTHPIECE?

GUMEASE DENTAL MOUTHPIECE is a medical device that received FDA 510(k) clearance on 2007-11-05. The listed applicant is Biomedevice , Ltd.. The 510(k) number is K072082.

When did GUMEASE DENTAL MOUTHPIECE receive FDA 510(k) clearance?

GUMEASE DENTAL MOUTHPIECE received FDA 510(k) clearance on 2007-11-05, under 510(k) number K072082.

Who is the listed applicant for GUMEASE DENTAL MOUTHPIECE?

The FDA 510(k) record lists Biomedevice , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUMEASE DENTAL MOUTHPIECE?

The FDA product code for GUMEASE DENTAL MOUTHPIECE is KKO.

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Related Devices (Code: KKO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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