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FDA 510(k)

ProMin Dental Desensitizing Gel

K-Number: K231060 · 2024-06-13

ApplicantBelport Company, Inc., Gingi-Pak
Decision Date2024-06-13
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ProMin Dental Desensitizing Gel is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K231060. 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 ProMin Dental Desensitizing Gel?

ProMin Dental Desensitizing Gel is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K231060.

When did ProMin Dental Desensitizing Gel receive FDA 510(k) clearance?

ProMin Dental Desensitizing Gel received FDA 510(k) clearance on 2024-06-13, under 510(k) number K231060.

Who is the listed applicant for ProMin Dental Desensitizing Gel?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProMin Dental Desensitizing Gel?

The FDA product code for ProMin Dental Desensitizing Gel 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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