FDA 510(k)

Dentium NR Line CAD/CAM Abutments

K-Number: K170384 · 2017-08-17

Decision Date2017-08-17

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Dentium NR Line CAD/CAM Abutments is a medical device manufactured by Dentium Co., Ltd.. It received FDA 510(k) clearance on 2017-08-17 under approval number K170384. 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 Dentium NR Line CAD/CAM Abutments?

Dentium NR Line CAD/CAM Abutments is a medical device that received FDA 510(k) clearance on 2017-08-17. It is manufactured by Dentium Co., Ltd.. The 510(k) number is K170384.

When was Dentium NR Line CAD/CAM Abutments approved by the FDA?

Dentium NR Line CAD/CAM Abutments received FDA 510(k) clearance on 2017-08-17, under approval number K170384.

What company makes Dentium NR Line CAD/CAM Abutments?

Dentium NR Line CAD/CAM Abutments is manufactured by Dentium Co., Ltd..

What is the FDA product code for Dentium NR Line CAD/CAM Abutments?

The FDA product code for Dentium NR Line CAD/CAM Abutments is NHA.

Other Devices by Dentium Co., Ltd.

K161713Dentium CAD/CAM Abutments K160828Dentium Implantium & SuperLine Prosthetics K160483Burn-out Cylinder and Angled Screw Abutments K153268NR Line Implant System K171126Implantium II K160965SuperLine

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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.