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FDA 510(k)

Allcem, Allcem Core

K-Number: K183465 · 2019-11-02

ApplicantDentscare Ltda
Decision Date2019-11-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Allcem, Allcem Core is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2019-11-02 under 510(k) number K183465. 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 Allcem, Allcem Core?

Allcem, Allcem Core is a medical device that received FDA 510(k) clearance on 2019-11-02. The listed applicant is Dentscare Ltda. The 510(k) number is K183465.

When did Allcem, Allcem Core receive FDA 510(k) clearance?

Allcem, Allcem Core received FDA 510(k) clearance on 2019-11-02, under 510(k) number K183465.

Who is the listed applicant for Allcem, Allcem Core?

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

What is the FDA product code for Allcem, Allcem Core?

The FDA product code for Allcem, Allcem Core is EMA.

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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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