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FDA 510(k)

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)

K-Number: K200555 · 2021-05-13

ApplicantPrevest Denpro Limited
Decision Date2021-05-13
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) is the device name listed in this FDA 510(k) record. The listed applicant is Prevest Denpro Limited. It received FDA 510(k) clearance on 2021-05-13 under 510(k) number K200555. 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 Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)?

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) is a medical device that received FDA 510(k) clearance on 2021-05-13. The listed applicant is Prevest Denpro Limited. The 510(k) number is K200555.

When did Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) receive FDA 510(k) clearance?

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) received FDA 510(k) clearance on 2021-05-13, under 510(k) number K200555.

Who is the listed applicant for Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)?

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

What is the FDA product code for Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)?

The FDA product code for Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) is EMA.

Related Clinical Trials

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.

NCT07290049Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without Laser TherapyCOMPLETEDNCT07507136Novel Dental Cements (ALBO-MPCA) in Patients With CariesCOMPLETED

Other records listing Prevest Denpro Limited 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.

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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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