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FDA 510(k)

Parkell Self-Adhesive Cement

K-Number: K210259 · 2022-01-20

ApplicantParkell, Inc.
Decision Date2022-01-20
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Parkell Self-Adhesive Cement is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K210259. 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 Parkell Self-Adhesive Cement?

Parkell Self-Adhesive Cement is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Parkell, Inc.. The 510(k) number is K210259.

When did Parkell Self-Adhesive Cement receive FDA 510(k) clearance?

Parkell Self-Adhesive Cement received FDA 510(k) clearance on 2022-01-20, under 510(k) number K210259.

Who is the listed applicant for Parkell Self-Adhesive Cement?

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

What is the FDA product code for Parkell Self-Adhesive Cement?

The FDA product code for Parkell Self-Adhesive Cement is EMA.

Other records listing Parkell, Inc. 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.

K243254Parkell Pit and Fissure SealantK191103Parkell Desensitizer GelK190930SmarTemp X1K182296HyperFil-LVK172176Parkell Universal Adhesive

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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