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FDA 510(k)

MICRODOSE DENTIN CONDITIONER

K-Number: K925162 · 1993-03-16

ApplicantUnicep
Decision Date1993-03-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICRODOSE DENTIN CONDITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Unicep. It received FDA 510(k) clearance on 1993-03-16 under 510(k) number K925162. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRODOSE DENTIN CONDITIONER?

MICRODOSE DENTIN CONDITIONER is a medical device that received FDA 510(k) clearance on 1993-03-16. The listed applicant is Unicep. The 510(k) number is K925162.

When did MICRODOSE DENTIN CONDITIONER receive FDA 510(k) clearance?

MICRODOSE DENTIN CONDITIONER received FDA 510(k) clearance on 1993-03-16, under 510(k) number K925162.

Who is the listed applicant for MICRODOSE DENTIN CONDITIONER?

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 DENTIN CONDITIONER?

The FDA product code for MICRODOSE DENTIN CONDITIONER is EBF.

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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 SILANEK924824MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITEK924825MICRODOSE RC-EZK924827MICRODOSE POTASSIUM OXYLATE

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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