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FDA 510(k)

CLEARFIL DC CORE PLUS

K-Number: K111982 · 2011-11-17

ApplicantKuraray America, Inc.
Decision Date2011-11-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL DC CORE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray America, Inc.. It received FDA 510(k) clearance on 2011-11-17 under 510(k) number K111982. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARFIL DC CORE PLUS?

CLEARFIL DC CORE PLUS is a medical device that received FDA 510(k) clearance on 2011-11-17. The listed applicant is Kuraray America, Inc.. The 510(k) number is K111982.

When did CLEARFIL DC CORE PLUS receive FDA 510(k) clearance?

CLEARFIL DC CORE PLUS received FDA 510(k) clearance on 2011-11-17, under 510(k) number K111982.

Who is the listed applicant for CLEARFIL DC CORE PLUS?

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

What is the FDA product code for CLEARFIL DC CORE PLUS?

The FDA product code for CLEARFIL DC CORE PLUS is EBF.

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Other records listing Kuraray America, Inc. as applicant

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.

K111980CLEARFIL TRI-S BOND PLUSK063595CLEARFIL MAJESTY POSTERIORK063593CLEARFIL MAJESTY FLOWK063228SURFACE COATK002322MODIFICATION TO PANAVIA FK983361PANAVIA F

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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