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FDA 510(k)

CLEARFIL TRI-S BOND

K-Number: K042913 · 2004-11-26

ApplicantKuraray Medical, Inc.
Decision Date2004-11-26
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL TRI-S 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 2004-11-26 under 510(k) number K042913. 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?

CLEARFIL TRI-S BOND is a medical device that received FDA 510(k) clearance on 2004-11-26. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K042913.

When did CLEARFIL TRI-S BOND receive FDA 510(k) clearance?

CLEARFIL TRI-S BOND received FDA 510(k) clearance on 2004-11-26, under 510(k) number K042913.

Who is the listed applicant for CLEARFIL TRI-S 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 TRI-S BOND?

The FDA product code for CLEARFIL TRI-S 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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