FDA 510(k)

4plus6Line Abutment System

K-Number: K151608 · 2016-04-13

Decision Date2016-04-13

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

4plus6Line Abutment System is a medical device manufactured by Ot Medical GmbH. It received FDA 510(k) clearance on 2016-04-13 under approval number K151608. 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 4plus6Line Abutment System?

4plus6Line Abutment System is a medical device that received FDA 510(k) clearance on 2016-04-13. It is manufactured by Ot Medical GmbH. The 510(k) number is K151608.

When was 4plus6Line Abutment System approved by the FDA?

4plus6Line Abutment System received FDA 510(k) clearance on 2016-04-13, under approval number K151608.

What company makes 4plus6Line Abutment System?

4plus6Line Abutment System is manufactured by Ot Medical GmbH.

What is the FDA product code for 4plus6Line Abutment System?

The FDA product code for 4plus6Line Abutment System 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.