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FDA 510(k)

CLEARFIL PHOTO BOND

K-Number: K943165 · 1994-08-10

ApplicantKuraray Company, Ltd.
Decision Date1994-08-10
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL PHOTO BOND is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Company, Ltd.. It received FDA 510(k) clearance on 1994-08-10 under 510(k) number K943165. 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 PHOTO BOND?

CLEARFIL PHOTO BOND is a medical device that received FDA 510(k) clearance on 1994-08-10. The listed applicant is Kuraray Company, Ltd.. The 510(k) number is K943165.

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

CLEARFIL PHOTO BOND received FDA 510(k) clearance on 1994-08-10, under 510(k) number K943165.

Who is the listed applicant for CLEARFIL PHOTO BOND?

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

What is the FDA product code for CLEARFIL PHOTO BOND?

The FDA product code for CLEARFIL PHOTO 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 Company, Ltd. 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.

K001914CLEARFIL REPAIRK001913CLEARFIL ST OPAQUERK980232CLEARFIL DC CEMENTK965091TEETHMATE F-1K943168CLEARFIL AP-XK943169CLEARFIL AP-X AND LINER BOND 2

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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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