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FDA 510(k)

NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING

K-Number: K033171 · 2004-04-27

ApplicantNorthern Implants, LLC
Decision Date2004-04-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING is the device name listed in this FDA 510(k) record. The listed applicant is Northern Implants, LLC. It received FDA 510(k) clearance on 2004-04-27 under 510(k) number K033171. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING?

NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING is a medical device that received FDA 510(k) clearance on 2004-04-27. The listed applicant is Northern Implants, LLC. The 510(k) number is K033171.

When did NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING receive FDA 510(k) clearance?

NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING received FDA 510(k) clearance on 2004-04-27, under 510(k) number K033171.

Who is the listed applicant for NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING?

The FDA 510(k) record lists Northern Implants, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING?

The FDA product code for NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING is DZE.

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.

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Other records listing Northern Implants, LLC 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.

K061169ENDOSSEOUS DENTAL IMPLANTK053478ENDOSSEOUS DENTAL IMPLANT SYSTEMK052490ENDOSSEOUS DENTAL IMPLANT SYSTEM

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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