FDA 510(k)

DIO CAD/CAM Abutment

K-Number: K181037 · 2018-12-21

Decision Date2018-12-21

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DIO CAD/CAM Abutment is a medical device manufactured by Dio Corporation. It received FDA 510(k) clearance on 2018-12-21 under approval 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. It is manufactured by Dio Corporation. The 510(k) number is K181037.

When was DIO CAD/CAM Abutment approved by the FDA?

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

What company makes DIO CAD/CAM Abutment?

DIO CAD/CAM Abutment is manufactured by Dio Corporation.

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

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

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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.