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FDA 510(k)

OrangeCAD Med Abutments

K-Number: K253312 · 2025-12-23

ApplicantOrangecad Med GmbH
Decision Date2025-12-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OrangeCAD Med Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Orangecad Med GmbH. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K253312. 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 OrangeCAD Med Abutments?

OrangeCAD Med Abutments is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Orangecad Med GmbH. The 510(k) number is K253312.

When did OrangeCAD Med Abutments receive FDA 510(k) clearance?

OrangeCAD Med Abutments received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253312.

Who is the listed applicant for OrangeCAD Med Abutments?

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

What is the FDA product code for OrangeCAD Med Abutments?

The FDA product code for OrangeCAD Med Abutments is NHA.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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