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FDA 510(k)

ATLANTIS Abutment for HIOSSEN ET implant

K-Number: K160626 · 2016-08-29

Decision Date2016-08-29
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS Abutment for HIOSSEN ET implant is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2016-08-29 under approval number K160626. 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 ATLANTIS Abutment for HIOSSEN ET implant?

ATLANTIS Abutment for HIOSSEN ET implant is a medical device that received FDA 510(k) clearance on 2016-08-29. It is manufactured by Dentsply Sirona. The 510(k) number is K160626.

When was ATLANTIS Abutment for HIOSSEN ET implant approved by the FDA?

ATLANTIS Abutment for HIOSSEN ET implant received FDA 510(k) clearance on 2016-08-29, under approval number K160626.

What company makes ATLANTIS Abutment for HIOSSEN ET implant?

ATLANTIS Abutment for HIOSSEN ET implant is manufactured by Dentsply Sirona.

What is the FDA product code for ATLANTIS Abutment for HIOSSEN ET implant?

The FDA product code for ATLANTIS Abutment for HIOSSEN ET implant 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.