FDA 510(k)

UF(II) Bar holder abutment

K-Number: K193404 · 2020-05-18

Decision Date2020-05-18

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

UF(II) Bar holder abutment is a medical device manufactured by Dio Corporation. It received FDA 510(k) clearance on 2020-05-18 under approval number K193404. 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) Bar holder abutment?

UF(II) Bar holder abutment is a medical device that received FDA 510(k) clearance on 2020-05-18. It is manufactured by Dio Corporation. The 510(k) number is K193404.

When was UF(II) Bar holder abutment approved by the FDA?

UF(II) Bar holder abutment received FDA 510(k) clearance on 2020-05-18, under approval number K193404.

What company makes UF(II) Bar holder abutment?

UF(II) Bar holder abutment is manufactured by Dio Corporation.

What is the FDA product code for UF(II) Bar holder abutment?

The FDA product code for UF(II) Bar holder abutment is NHA.

Other Devices by Dio Corporation

K161987UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure K181037DIO CAD/CAM Abutment K182194UV Active Implant System K173975UF(II) Wide Fixture K170608UF(II) Implant System K190048UF(II) Anatomic abutment

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Related Devices (Code: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

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.