FDA 510(k)

Parkell Universal Adhesive

K-Number: K172176 · 2017-11-21

Decision Date2017-11-21

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Parkell Universal Adhesive is a medical device manufactured by Parkell, Inc.. It received FDA 510(k) clearance on 2017-11-21 under approval number K172176. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Parkell Universal Adhesive?

Parkell Universal Adhesive is a medical device that received FDA 510(k) clearance on 2017-11-21. It is manufactured by Parkell, Inc.. The 510(k) number is K172176.

When was Parkell Universal Adhesive approved by the FDA?

Parkell Universal Adhesive received FDA 510(k) clearance on 2017-11-21, under approval number K172176.

What company makes Parkell Universal Adhesive?

Parkell Universal Adhesive is manufactured by Parkell, Inc..

What is the FDA product code for Parkell Universal Adhesive?

The FDA product code for Parkell Universal Adhesive is KLE.

Other Devices by Parkell, Inc.

K182296HyperFil-LV K191103Parkell Desensitizer Gel K190930SmarTemp X1 K210259Parkell Self-Adhesive Cement K243254Parkell Pit and Fissure Sealant

Related Devices (Code: KLE)

K161891HC PrimerShofu Dental Corporation K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value packKuraray Noritake Dental, Inc. K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. K171226TOKUYAMA UNIVERSAL BONDTokuyama Dental Corporation K172106SHOFU MZ Primer PlusShofu Dental Corporation K161077RnD TE and RnD SEApex Dental Materials, 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.