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FDA 510(k)

COSMEDENT BRUSHABLE COMPOSITE

K-Number: K092730 · 2009-11-20

ApplicantCosmedent, Inc.
Decision Date2009-11-20
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COSMEDENT BRUSHABLE COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2009-11-20 under 510(k) number K092730. 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 COSMEDENT BRUSHABLE COMPOSITE?

COSMEDENT BRUSHABLE COMPOSITE is a medical device that received FDA 510(k) clearance on 2009-11-20. The listed applicant is Cosmedent, Inc.. The 510(k) number is K092730.

When did COSMEDENT BRUSHABLE COMPOSITE receive FDA 510(k) clearance?

COSMEDENT BRUSHABLE COMPOSITE received FDA 510(k) clearance on 2009-11-20, under 510(k) number K092730.

Who is the listed applicant for COSMEDENT BRUSHABLE COMPOSITE?

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

What is the FDA product code for COSMEDENT BRUSHABLE COMPOSITE?

The FDA product code for COSMEDENT BRUSHABLE COMPOSITE is EBF.

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Other records listing Cosmedent, Inc. as applicant

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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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