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FDA 510(k)

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants

K-Number: K251205 · 2025-11-21

ApplicantDentsply Sirona
Decision Date2025-11-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K251205. 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 for Straumann BLX and Neodent GM Implants?

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Dentsply Sirona. The 510(k) number is K251205.

When did Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants receive FDA 510(k) clearance?

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants received FDA 510(k) clearance on 2025-11-21, under 510(k) number K251205.

Who is the listed applicant for Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants?

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 for Straumann BLX and Neodent GM Implants?

The FDA product code for Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants is NHA.

Related Clinical Trials

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.

NCT03908177Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.COMPLETED

Other records listing Dentsply Sirona as applicant

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K260785DS Core CBCT AnatomyK260722SureSmile Aligner (ASSY500020)K253565SureSmile SoftwareK251614Stainless Steel Surgical KitsK253959Primevision 3DK253009DS Core Detect

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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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