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FDA 510(k)

CLEARFIL SE BOND

K-Number: K990040 · 1999-02-04

ApplicantKuraray Co.
Decision Date1999-02-04
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL SE BOND is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Co.. It received FDA 510(k) clearance on 1999-02-04 under 510(k) number K990040. 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 SE BOND?

CLEARFIL SE BOND is a medical device that received FDA 510(k) clearance on 1999-02-04. The listed applicant is Kuraray Co.. The 510(k) number is K990040.

When did CLEARFIL SE BOND receive FDA 510(k) clearance?

CLEARFIL SE BOND received FDA 510(k) clearance on 1999-02-04, under 510(k) number K990040.

Who is the listed applicant for CLEARFIL SE BOND?

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

What is the FDA product code for CLEARFIL SE BOND?

The FDA product code for CLEARFIL SE BOND is KLE.

Related Clinical Trials

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.

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Other records listing Kuraray Co. 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.

K951813CARIES DETECTORK933030PANAVIA 21K925383PHOTO CLEARFIL OPAQUERK925404CLEARFIL PORCELAIN BOND ACTIVATORK912707CLEARFIL LINER BOND SYSTEMK912708CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM

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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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