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FDA 510(k)

CLEARFIL LINER BOND 2

K-Number: K936100 · 1994-02-03

ApplicantKuraray Intl. Corp.
Decision Date1994-02-03
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL LINER BOND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Intl. Corp.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K936100. 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 LINER BOND 2?

CLEARFIL LINER BOND 2 is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Kuraray Intl. Corp.. The 510(k) number is K936100.

When did CLEARFIL LINER BOND 2 receive FDA 510(k) clearance?

CLEARFIL LINER BOND 2 received FDA 510(k) clearance on 1994-02-03, under 510(k) number K936100.

Who is the listed applicant for CLEARFIL LINER BOND 2?

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

What is the FDA product code for CLEARFIL LINER BOND 2?

The FDA product code for CLEARFIL LINER BOND 2 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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