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FDA 510(k)

U-Cem Premium & MAZIC Cem

K-Number: K193260 · 2020-08-21

ApplicantVericom Co., Ltd.
Decision Date2020-08-21
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

U-Cem Premium & MAZIC Cem is the device name listed in this FDA 510(k) record. The listed applicant is Vericom Co., Ltd.. It received FDA 510(k) clearance on 2020-08-21 under 510(k) number K193260. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U-Cem Premium & MAZIC Cem?

U-Cem Premium & MAZIC Cem is a medical device that received FDA 510(k) clearance on 2020-08-21. The listed applicant is Vericom Co., Ltd.. The 510(k) number is K193260.

When did U-Cem Premium & MAZIC Cem receive FDA 510(k) clearance?

U-Cem Premium & MAZIC Cem received FDA 510(k) clearance on 2020-08-21, under 510(k) number K193260.

Who is the listed applicant for U-Cem Premium & MAZIC Cem?

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

What is the FDA product code for U-Cem Premium & MAZIC Cem?

The FDA product code for U-Cem Premium & MAZIC Cem is EMA.

Other records listing Vericom Co., Ltd. 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.

K260805Dual CoreK252285Well-Root PTK203672MAZIC Claro CAD and MAZIC Claro PressK170950Well-Root STK163346MAZIC DuroK160377V-varnish Premium

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Related Devices (Code: EMA)

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.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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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