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FDA 510(k)

DIO CAD/CAM Abutment

K-Number: K181037 · 2018-12-21

ApplicantDio Corporation
Decision Date2018-12-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIO CAD/CAM Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K181037. 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 DIO CAD/CAM Abutment?

DIO CAD/CAM Abutment is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Dio Corporation. The 510(k) number is K181037.

When did DIO CAD/CAM Abutment receive FDA 510(k) clearance?

DIO CAD/CAM Abutment received FDA 510(k) clearance on 2018-12-21, under 510(k) number K181037.

Who is the listed applicant for DIO CAD/CAM Abutment?

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

What is the FDA product code for DIO CAD/CAM Abutment?

The FDA product code for DIO CAD/CAM Abutment is NHA.

Other records listing Dio Corporation 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.

K220253Eco Abutment, Multiunit AbutmentK210828DIOnavi-Denture02K193623DIOnavi-DentureK193404UF(II) Bar holder abutmentK192263UCLA CCM AbutmentK190048UF(II) Anatomic 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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