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FDA 510(k)

SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL

K-Number: K110484 · 2011-05-17

ApplicantNovocol, Inc.
Decision Date2011-05-17
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SELF CURE TEMPORARY CROWN AND BRIDGE 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 2011-05-17 under 510(k) number K110484. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL?

SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL is a medical device that received FDA 510(k) clearance on 2011-05-17. The listed applicant is Novocol, Inc.. The 510(k) number is K110484.

When did SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL receive FDA 510(k) clearance?

SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL received FDA 510(k) clearance on 2011-05-17, under 510(k) number K110484.

Who is the listed applicant for SELF CURE TEMPORARY CROWN AND BRIDGE 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 SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL?

The FDA product code for SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL is EBG.

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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 ADHESIVEK092501LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIALK072150DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL

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Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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