FDA 510(k)

Parkell Self-Adhesive Cement

K-Number: K210259 · 2022-01-20

Decision Date2022-01-20

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Parkell Self-Adhesive Cement is a medical device manufactured by Parkell, Inc.. It received FDA 510(k) clearance on 2022-01-20 under approval 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. It is manufactured by Parkell, Inc.. The 510(k) number is K210259.

When was Parkell Self-Adhesive Cement approved by the FDA?

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

What company makes Parkell Self-Adhesive Cement?

Parkell Self-Adhesive Cement is manufactured by Parkell, Inc..

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

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

Other Devices by Parkell, Inc.

K172176Parkell Universal Adhesive K182296HyperFil-LV K191103Parkell Desensitizer Gel K190930SmarTemp X1 K243254Parkell Pit and Fissure Sealant

Related Devices (Code: EMA)

K160800DuoCemColtene/Whaledent AG K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation K160443TempoCem ClearDmg USA, Inc. K160774IonoStar PlusVoco GmbH K161256TheraCemBisco, Inc. K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.