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FDA 510(k)

CLEARFIL LINER BOND 2V

K-Number: K974486 · 1998-01-29

ApplicantKuraray America, Inc.
Decision Date1998-01-29
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL LINER BOND 2V is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray America, Inc.. It received FDA 510(k) clearance on 1998-01-29 under 510(k) number K974486. 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 LINER BOND 2V?

CLEARFIL LINER BOND 2V is a medical device that received FDA 510(k) clearance on 1998-01-29. The listed applicant is Kuraray America, Inc.. The 510(k) number is K974486.

When did CLEARFIL LINER BOND 2V receive FDA 510(k) clearance?

CLEARFIL LINER BOND 2V received FDA 510(k) clearance on 1998-01-29, under 510(k) number K974486.

Who is the listed applicant for CLEARFIL LINER BOND 2V?

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

What is the FDA product code for CLEARFIL LINER BOND 2V?

The FDA product code for CLEARFIL LINER BOND 2V is KLE.

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Other records listing Kuraray America, 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.

K111982CLEARFIL DC CORE PLUSK111980CLEARFIL TRI-S BOND PLUSK063595CLEARFIL MAJESTY POSTERIORK063593CLEARFIL MAJESTY FLOWK063228SURFACE COATK002322MODIFICATION TO PANAVIA F

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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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