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FDA 510(k)

ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT

K-Number: K101005 · 2011-06-21

ApplicantAstra Tech AB
Decision Date2011-06-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Astra Tech AB. It received FDA 510(k) clearance on 2011-06-21 under 510(k) number K101005. 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 ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT?

ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT is a medical device that received FDA 510(k) clearance on 2011-06-21. The listed applicant is Astra Tech AB. The 510(k) number is K101005.

When did ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT receive FDA 510(k) clearance?

ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT received FDA 510(k) clearance on 2011-06-21, under 510(k) number K101005.

Who is the listed applicant for ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT?

The FDA 510(k) record lists Astra Tech AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT?

The FDA product code for ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT is NHA.

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Other records listing Astra Tech AB 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.

K121810OSSEOSPEED ANGLED ABUTMENT EVK120414OSSEOSPEED PLUSK113424LOFRIC SINGLE USE URINARY CATHETERK111287ASTRA TECH IMPLANT SYSTEMK101732ASTRA TECH IMPLANT SYSTEMK091239ASTRA TECH IMPLANT SYSTEM

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Related Devices (Code: NHA)

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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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