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FDA 510(k)

CreoDent Solidex Customized Abutment and Screw

K-Number: K170100 · 2017-07-18

ApplicantCreodent Prosthetics, Ltd.
Decision Date2017-07-18
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CreoDent Solidex Customized Abutment and Screw is the device name listed in this FDA 510(k) record. The listed applicant is Creodent Prosthetics, Ltd.. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K170100. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CreoDent Solidex Customized Abutment and Screw?

CreoDent Solidex Customized Abutment and Screw is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Creodent Prosthetics, Ltd.. The 510(k) number is K170100.

When did CreoDent Solidex Customized Abutment and Screw receive FDA 510(k) clearance?

CreoDent Solidex Customized Abutment and Screw received FDA 510(k) clearance on 2017-07-18, under 510(k) number K170100.

Who is the listed applicant for CreoDent Solidex Customized Abutment and Screw?

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

What is the FDA product code for CreoDent Solidex Customized Abutment and Screw?

The FDA product code for CreoDent Solidex Customized Abutment and Screw is NHA.

Other records listing Creodent Prosthetics, 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.

K220390CreoDent Solidex Customized Abutment and ScrewK211427CREOKORREKT AlignersK202909CreoDent Solidex Customized AbutmentK202095CreoDent Solidex Customized Abutment and ScrewK162734CreoDent Solidex Customized AbutmentK160436CreoDent Solidex Custom Abutment

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Related Devices (Code: NHA)

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.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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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