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FDA 510(k)

Atlantis Abutment for MIS Implant

K-Number: K172225 · 2017-11-30

ApplicantDentsply Sirona
Decision Date2017-11-30
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Atlantis Abutment for MIS Implant is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2017-11-30 under 510(k) number K172225. 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 MIS Implant?

Atlantis Abutment for MIS Implant is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is Dentsply Sirona. The 510(k) number is K172225.

When did Atlantis Abutment for MIS Implant receive FDA 510(k) clearance?

Atlantis Abutment for MIS Implant received FDA 510(k) clearance on 2017-11-30, under 510(k) number K172225.

Who is the listed applicant for Atlantis Abutment for MIS Implant?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atlantis Abutment for MIS Implant?

The FDA product code for Atlantis Abutment for MIS Implant is NHA.

Other records listing Dentsply Sirona as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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.

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