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FDA 510(k)

PROTECT TOOTH DESENSITIZER

K-Number: K050486 · 2005-06-07

ApplicantSunstar Butler
Decision Date2005-06-07
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROTECT TOOTH DESENSITIZER is the device name listed in this FDA 510(k) record. The listed applicant is Sunstar Butler. It received FDA 510(k) clearance on 2005-06-07 under 510(k) number K050486. 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 PROTECT TOOTH DESENSITIZER?

PROTECT TOOTH DESENSITIZER is a medical device that received FDA 510(k) clearance on 2005-06-07. The listed applicant is Sunstar Butler. The 510(k) number is K050486.

When did PROTECT TOOTH DESENSITIZER receive FDA 510(k) clearance?

PROTECT TOOTH DESENSITIZER received FDA 510(k) clearance on 2005-06-07, under 510(k) number K050486.

Who is the listed applicant for PROTECT TOOTH DESENSITIZER?

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

What is the FDA product code for PROTECT TOOTH DESENSITIZER?

The FDA product code for PROTECT TOOTH DESENSITIZER is LBH.

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Related Devices (Code: LBH)

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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