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FDA 510(k)

CLEARFIL PROTECT BOND

K-Number: K033938 · 2004-01-29

ApplicantKuraray Medical, Inc.
Decision Date2004-01-29
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL PROTECT BOND 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 2004-01-29 under 510(k) number K033938. 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 PROTECT BOND?

CLEARFIL PROTECT BOND is a medical device that received FDA 510(k) clearance on 2004-01-29. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K033938.

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

CLEARFIL PROTECT BOND received FDA 510(k) clearance on 2004-01-29, under 510(k) number K033938.

Who is the listed applicant for CLEARFIL PROTECT BOND?

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 PROTECT BOND?

The FDA product code for CLEARFIL PROTECT BOND 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.

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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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