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FDA 510(k)

MICRODOSE POTASSIUM OXYLATE

K-Number: K924827 · 1993-03-05

ApplicantUnicep
Decision Date1993-03-05
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICRODOSE POTASSIUM OXYLATE is the device name listed in this FDA 510(k) record. The listed applicant is Unicep. It received FDA 510(k) clearance on 1993-03-05 under 510(k) number K924827. 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 MICRODOSE POTASSIUM OXYLATE?

MICRODOSE POTASSIUM OXYLATE is a medical device that received FDA 510(k) clearance on 1993-03-05. The listed applicant is Unicep. The 510(k) number is K924827.

When did MICRODOSE POTASSIUM OXYLATE receive FDA 510(k) clearance?

MICRODOSE POTASSIUM OXYLATE received FDA 510(k) clearance on 1993-03-05, under 510(k) number K924827.

Who is the listed applicant for MICRODOSE POTASSIUM OXYLATE?

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

What is the FDA product code for MICRODOSE POTASSIUM OXYLATE?

The FDA product code for MICRODOSE POTASSIUM OXYLATE is LBH.

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Other records listing Unicep as applicant

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.

K925163MICODOSE CHLORHEXIPREPK924821MICRODOSE PORCELAIN ETCHANTK924823MICRODOSE SILANEK925162MICRODOSE DENTIN CONDITIONERK924824MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITEK924825MICRODOSE RC-EZ

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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.

K262243Profisil FreeKettenbach GmbH & Co. KGK253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, Inc.

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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