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FDA 510(k)

BPA-FREE MICROHYBID COMPOSITE

K-Number: K120237 · 2012-12-11

ApplicantNovocol, Inc.
Decision Date2012-12-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BPA-FREE MICROHYBID COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Novocol, Inc.. It received FDA 510(k) clearance on 2012-12-11 under 510(k) number K120237. 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 BPA-FREE MICROHYBID COMPOSITE?

BPA-FREE MICROHYBID COMPOSITE is a medical device that received FDA 510(k) clearance on 2012-12-11. The listed applicant is Novocol, Inc.. The 510(k) number is K120237.

When did BPA-FREE MICROHYBID COMPOSITE receive FDA 510(k) clearance?

BPA-FREE MICROHYBID COMPOSITE received FDA 510(k) clearance on 2012-12-11, under 510(k) number K120237.

Who is the listed applicant for BPA-FREE MICROHYBID COMPOSITE?

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

What is the FDA product code for BPA-FREE MICROHYBID COMPOSITE?

The FDA product code for BPA-FREE MICROHYBID COMPOSITE is EBF.

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Other records listing Novocol, 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.

K130601BIOROOT RCSK120283DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENTK120619ORTHODONTIC FLOWABLE BRACKET ADHESIVEK110484SELF CURE TEMPORARY CROWN AND BRIDGE MATERIALK092501LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIALK072150DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL

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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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