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FDA 510(k)

GINDA GUARD

K-Number: K011239 · 2002-02-14

ApplicantCosmedent, Inc.
Decision Date2002-02-14
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GINDA GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2002-02-14 under 510(k) number K011239. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GINDA GUARD?

GINDA GUARD is a medical device that received FDA 510(k) clearance on 2002-02-14. The listed applicant is Cosmedent, Inc.. The 510(k) number is K011239.

When did GINDA GUARD receive FDA 510(k) clearance?

GINDA GUARD received FDA 510(k) clearance on 2002-02-14, under 510(k) number K011239.

Who is the listed applicant for GINDA GUARD?

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

What is the FDA product code for GINDA GUARD?

The FDA product code for GINDA GUARD is EBD.

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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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