FDA 510(k)

EASY BOND

K-Number: K972421 · 1997-08-29

Decision Date1997-08-29

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

EASY BOND is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1997-08-29 under 510(k) number K972421. 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 EASY BOND?

EASY BOND is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Parkell, Inc.. The 510(k) number is K972421.

When did EASY BOND receive FDA 510(k) clearance?

EASY BOND received FDA 510(k) clearance on 1997-08-29, under 510(k) number K972421.

Who is the listed applicant for EASY BOND?

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 EASY BOND?

The FDA product code for EASY BOND is KLE.

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 Sealant K210259Parkell Self-Adhesive Cement K191103Parkell Desensitizer Gel K190930SmarTemp X1 K182296HyperFil-LV K172176Parkell Universal Adhesive

View all 50 devices →

Related Devices (Code: KLE)

K262252MPa Max adhesiveDen-Mat Holdings, LLC K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products Company K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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.