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FDA 510(k)

Burn-out Cylinder and Angled Screw Abutments

K-Number: K160483 · 2016-08-05

Decision Date2016-08-05
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Burn-out Cylinder and Angled Screw Abutments is a medical device manufactured by Dentium Co., Ltd.. It received FDA 510(k) clearance on 2016-08-05 under approval number K160483. 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 Burn-out Cylinder and Angled Screw Abutments?

Burn-out Cylinder and Angled Screw Abutments is a medical device that received FDA 510(k) clearance on 2016-08-05. It is manufactured by Dentium Co., Ltd.. The 510(k) number is K160483.

When was Burn-out Cylinder and Angled Screw Abutments approved by the FDA?

Burn-out Cylinder and Angled Screw Abutments received FDA 510(k) clearance on 2016-08-05, under approval number K160483.

What company makes Burn-out Cylinder and Angled Screw Abutments?

Burn-out Cylinder and Angled Screw Abutments is manufactured by Dentium Co., Ltd..

What is the FDA product code for Burn-out Cylinder and Angled Screw Abutments?

The FDA product code for Burn-out Cylinder and Angled Screw Abutments is NHA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.