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FDA 510(k)

UF(II) Anatomic abutment

K-Number: K190048 · 2019-09-30

ApplicantDio Corporation
Decision Date2019-09-30
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UF(II) Anatomic 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 2019-09-30 under 510(k) number K190048. 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 UF(II) Anatomic abutment?

UF(II) Anatomic abutment is a medical device that received FDA 510(k) clearance on 2019-09-30. The listed applicant is Dio Corporation. The 510(k) number is K190048.

When did UF(II) Anatomic abutment receive FDA 510(k) clearance?

UF(II) Anatomic abutment received FDA 510(k) clearance on 2019-09-30, under 510(k) number K190048.

Who is the listed applicant for UF(II) Anatomic 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 UF(II) Anatomic abutment?

The FDA product code for UF(II) Anatomic 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 AbutmentK181037DIO CAD/CAM 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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