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FDA 510(k)

MIRUSCONE ABUTMENT SYSTEM

K-Number: K961728 · 1996-07-10

ApplicantNobelpharma USA, Inc.
Decision Date1996-07-10
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIRUSCONE ABUTMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nobelpharma USA, Inc.. It received FDA 510(k) clearance on 1996-07-10 under 510(k) number K961728. 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 MIRUSCONE ABUTMENT SYSTEM?

MIRUSCONE ABUTMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-07-10. The listed applicant is Nobelpharma USA, Inc.. The 510(k) number is K961728.

When did MIRUSCONE ABUTMENT SYSTEM receive FDA 510(k) clearance?

MIRUSCONE ABUTMENT SYSTEM received FDA 510(k) clearance on 1996-07-10, under 510(k) number K961728.

Who is the listed applicant for MIRUSCONE ABUTMENT SYSTEM?

The FDA 510(k) record lists Nobelpharma USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIRUSCONE ABUTMENT SYSTEM?

The FDA product code for MIRUSCONE ABUTMENT SYSTEM is NHA.

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Other records listing Nobelpharma USA, Inc. 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.

K984162BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USEK962403NOBLEPHARMA WIDE ACCESSORIESK955713NOBELPHARMA BONE ANCHORED HEARING AIDK962130BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTUREK96173617 ANGULATED ABUTMENTK961737CERA ONE ABUTMENT SYSTEM

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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.

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal 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.

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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