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FDA 510(k)

GLUMA DESENSITIZER POWER GEL

K-Number: K093575 · 2010-03-05

ApplicantHeraeus Kulzer, LLC
Decision Date2010-03-05
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLUMA DESENSITIZER POWER GEL is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, LLC. It received FDA 510(k) clearance on 2010-03-05 under 510(k) number K093575. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUMA DESENSITIZER POWER GEL?

GLUMA DESENSITIZER POWER GEL is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Heraeus Kulzer, LLC. The 510(k) number is K093575.

When did GLUMA DESENSITIZER POWER GEL receive FDA 510(k) clearance?

GLUMA DESENSITIZER POWER GEL received FDA 510(k) clearance on 2010-03-05, under 510(k) number K093575.

Who is the listed applicant for GLUMA DESENSITIZER POWER GEL?

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

What is the FDA product code for GLUMA DESENSITIZER POWER GEL?

The FDA product code for GLUMA DESENSITIZER POWER GEL is LBH.

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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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