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FDA 510(k)

Atlantis® Abutments in Titanium

K-Number: K250081 · 2025-04-11

ApplicantDentsply Sirona
Decision Date2025-04-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Atlantis® Abutments in Titanium is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K250081. 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® Abutments in Titanium?

Atlantis® Abutments in Titanium is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Dentsply Sirona. The 510(k) number is K250081.

When did Atlantis® Abutments in Titanium receive FDA 510(k) clearance?

Atlantis® Abutments in Titanium received FDA 510(k) clearance on 2025-04-11, under 510(k) number K250081.

Who is the listed applicant for Atlantis® Abutments in Titanium?

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® Abutments in Titanium?

The FDA product code for Atlantis® Abutments in Titanium is NHA.

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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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