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FDA 510(k)

CLEARFIL SE BOND PLUS

K-Number: K023842 · 2003-02-11

ApplicantKuraray Medical, Inc.
Decision Date2003-02-11
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL SE BOND PLUS 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 2003-02-11 under 510(k) number K023842. 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 PLUS?

CLEARFIL SE BOND PLUS is a medical device that received FDA 510(k) clearance on 2003-02-11. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K023842.

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

CLEARFIL SE BOND PLUS received FDA 510(k) clearance on 2003-02-11, under 510(k) number K023842.

Who is the listed applicant for CLEARFIL SE BOND PLUS?

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 SE BOND PLUS?

The FDA product code for CLEARFIL SE BOND PLUS 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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