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FDA 510(k)

CLEARFIL REPAIR

K-Number: K012729 · 2001-09-13

ApplicantKuraray Medical, Inc.
Decision Date2001-09-13
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL REPAIR 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 2001-09-13 under 510(k) number K012729. 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 REPAIR?

CLEARFIL REPAIR is a medical device that received FDA 510(k) clearance on 2001-09-13. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K012729.

When did CLEARFIL REPAIR receive FDA 510(k) clearance?

CLEARFIL REPAIR received FDA 510(k) clearance on 2001-09-13, under 510(k) number K012729.

Who is the listed applicant for CLEARFIL REPAIR?

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 REPAIR?

The FDA product code for CLEARFIL REPAIR 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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