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FDA 510(k)

CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK

K-Number: K111975 · 2011-10-14

ApplicantKuraray Medical, Inc.
Decision Date2011-10-14
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Medical, Inc.. It received FDA 510(k) clearance on 2011-10-14 under 510(k) number K111975. 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 PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK?

CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK is a medical device that received FDA 510(k) clearance on 2011-10-14. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K111975.

When did CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK receive FDA 510(k) clearance?

CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK received FDA 510(k) clearance on 2011-10-14, under 510(k) number K111975.

Who is the listed applicant for CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK?

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

What is the FDA product code for CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK?

The FDA product code for CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK is KLE.

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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

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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