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FDA 510(k)

CLEARFIL SA PRIMER

K-Number: K021427 · 2002-06-07

ApplicantKuraray Medical, Inc.
Decision Date2002-06-07
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL SA PRIMER 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 2002-06-07 under 510(k) number K021427. 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 SA PRIMER?

CLEARFIL SA PRIMER is a medical device that received FDA 510(k) clearance on 2002-06-07. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K021427.

When did CLEARFIL SA PRIMER receive FDA 510(k) clearance?

CLEARFIL SA PRIMER received FDA 510(k) clearance on 2002-06-07, under 510(k) number K021427.

Who is the listed applicant for CLEARFIL SA PRIMER?

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 SA PRIMER?

The FDA product code for CLEARFIL SA PRIMER 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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