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FDA 510(k)

LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL

K-Number: K980800 · 1998-11-09

ApplicantCosmedent, Inc.
Decision Date1998-11-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 1998-11-09 under 510(k) number K980800. 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 LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL?

LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL is a medical device that received FDA 510(k) clearance on 1998-11-09. The listed applicant is Cosmedent, Inc.. The 510(k) number is K980800.

When did LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL receive FDA 510(k) clearance?

LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL received FDA 510(k) clearance on 1998-11-09, under 510(k) number K980800.

Who is the listed applicant for LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL?

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 LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL?

The FDA product code for LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL is EBF.

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Other records listing Cosmedent, Inc. as applicant

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Related Devices (Code: EBF)

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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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