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FDA 510(k)

ENDOSSEOUS DENTAL IMPLANT SYSTEM

K-Number: K052490 · 2005-12-08

ApplicantNorthern Implants, LLC
Decision Date2005-12-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDOSSEOUS DENTAL IMPLANT SYSTEM 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 2005-12-08 under 510(k) number K052490. 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 ENDOSSEOUS DENTAL IMPLANT SYSTEM?

ENDOSSEOUS DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-08. The listed applicant is Northern Implants, LLC. The 510(k) number is K052490.

When did ENDOSSEOUS DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

ENDOSSEOUS DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2005-12-08, under 510(k) number K052490.

Who is the listed applicant for ENDOSSEOUS DENTAL IMPLANT SYSTEM?

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 ENDOSSEOUS DENTAL IMPLANT SYSTEM?

The FDA product code for ENDOSSEOUS DENTAL IMPLANT SYSTEM 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 SYSTEMK033171NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING

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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