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FDA 510(k)

ULTRAEZ DESENSITIZING GEL

K-Number: K061438 · 2007-06-12

ApplicantUltradent Products, Inc.
Decision Date2007-06-12
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRAEZ DESENSITIZING GEL is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2007-06-12 under 510(k) number K061438. 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 ULTRAEZ DESENSITIZING GEL?

ULTRAEZ DESENSITIZING GEL is a medical device that received FDA 510(k) clearance on 2007-06-12. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K061438.

When did ULTRAEZ DESENSITIZING GEL receive FDA 510(k) clearance?

ULTRAEZ DESENSITIZING GEL received FDA 510(k) clearance on 2007-06-12, under 510(k) number K061438.

Who is the listed applicant for ULTRAEZ DESENSITIZING GEL?

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

What is the FDA product code for ULTRAEZ DESENSITIZING GEL?

The FDA product code for ULTRAEZ DESENSITIZING GEL is LBH.

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Related Devices (Code: 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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