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FDA 510(k)

CLEARFIL TRI-S BOND SINGLE DOSE

K-Number: K051796 · 2005-08-09

ApplicantKuraray Medical Kurashiki Plant
Decision Date2005-08-09
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL TRI-S BOND SINGLE DOSE is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Medical Kurashiki Plant. It received FDA 510(k) clearance on 2005-08-09 under 510(k) number K051796. 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 CLEARFIL TRI-S BOND SINGLE DOSE?

CLEARFIL TRI-S BOND SINGLE DOSE is a medical device that received FDA 510(k) clearance on 2005-08-09. The listed applicant is Kuraray Medical Kurashiki Plant. The 510(k) number is K051796.

When did CLEARFIL TRI-S BOND SINGLE DOSE receive FDA 510(k) clearance?

CLEARFIL TRI-S BOND SINGLE DOSE received FDA 510(k) clearance on 2005-08-09, under 510(k) number K051796.

Who is the listed applicant for CLEARFIL TRI-S BOND SINGLE DOSE?

The FDA 510(k) record lists Kuraray Medical Kurashiki Plant as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARFIL TRI-S BOND SINGLE DOSE?

The FDA product code for CLEARFIL TRI-S BOND SINGLE DOSE is KLE.

Related Clinical Trials

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Other records listing Kuraray Medical Kurashiki Plant 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.

K042929ESTENIA C&B

Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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.

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