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FDA 510(k)

Pre-Milled Blank

K-Number: K193425 · 2020-03-09

ApplicantArum Dentistry Co., Ltd.
Decision Date2020-03-09
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Pre-Milled Blank is the device name listed in this FDA 510(k) record. The listed applicant is Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2020-03-09 under 510(k) number K193425. 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 Pre-Milled Blank?

Pre-Milled Blank is a medical device that received FDA 510(k) clearance on 2020-03-09. The listed applicant is Arum Dentistry Co., Ltd.. The 510(k) number is K193425.

When did Pre-Milled Blank receive FDA 510(k) clearance?

Pre-Milled Blank received FDA 510(k) clearance on 2020-03-09, under 510(k) number K193425.

Who is the listed applicant for Pre-Milled Blank?

The FDA 510(k) record lists Arum Dentistry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pre-Milled Blank?

The FDA product code for Pre-Milled Blank 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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