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FDA 510(k)

LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL

K-Number: K092501 · 2009-11-12

ApplicantNovocol, Inc.
Decision Date2009-11-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Novocol, Inc.. It received FDA 510(k) clearance on 2009-11-12 under 510(k) number K092501. 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 LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL?

LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL is a medical device that received FDA 510(k) clearance on 2009-11-12. The listed applicant is Novocol, Inc.. The 510(k) number is K092501.

When did LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL receive FDA 510(k) clearance?

LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL received FDA 510(k) clearance on 2009-11-12, under 510(k) number K092501.

Who is the listed applicant for LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL?

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 LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL?

The FDA product code for LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL 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 RCSK120237BPA-FREE MICROHYBID COMPOSITEK120283DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENTK120619ORTHODONTIC FLOWABLE BRACKET ADHESIVEK110484SELF CURE TEMPORARY CROWN AND BRIDGE 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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