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FDA 510(k)

EVADYNE TEMPORARY CROWN AND BRIDGE RESIN

K-Number: K111666 · 2011-09-07

ApplicantNeodental Chemical Products Co., Ltd.
Decision Date2011-09-07
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EVADYNE TEMPORARY CROWN AND BRIDGE RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Neodental Chemical Products Co., Ltd.. It received FDA 510(k) clearance on 2011-09-07 under 510(k) number K111666. 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 EVADYNE TEMPORARY CROWN AND BRIDGE RESIN?

EVADYNE TEMPORARY CROWN AND BRIDGE RESIN is a medical device that received FDA 510(k) clearance on 2011-09-07. The listed applicant is Neodental Chemical Products Co., Ltd.. The 510(k) number is K111666.

When did EVADYNE TEMPORARY CROWN AND BRIDGE RESIN receive FDA 510(k) clearance?

EVADYNE TEMPORARY CROWN AND BRIDGE RESIN received FDA 510(k) clearance on 2011-09-07, under 510(k) number K111666.

Who is the listed applicant for EVADYNE TEMPORARY CROWN AND BRIDGE RESIN?

The FDA 510(k) record lists Neodental Chemical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVADYNE TEMPORARY CROWN AND BRIDGE RESIN?

The FDA product code for EVADYNE TEMPORARY CROWN AND BRIDGE RESIN is EBG.

Related Clinical Trials

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.

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Other records listing Neodental Chemical Products Co., Ltd. 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.

K111668CAVIOS CAVITY LINERK973667VITAPEX PRE-LOADED DENTAL SYRINGEK971642DENTALIS KEZ ENDODONITC SEALERK955703NEO DENTAL ENDODONTIC IRRIGATION SYRINGE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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