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FDA 510(k)

4.0MM SIMPLER ONE THREADED DENTAL IMPLANT

K-Number: K974401 · 1998-02-23

ApplicantVancouver Implant Resources, Inc.
Decision Date1998-02-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

4.0MM SIMPLER ONE THREADED DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Vancouver Implant Resources, Inc.. It received FDA 510(k) clearance on 1998-02-23 under 510(k) number K974401. 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 4.0MM SIMPLER ONE THREADED DENTAL IMPLANT?

4.0MM SIMPLER ONE THREADED DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1998-02-23. The listed applicant is Vancouver Implant Resources, Inc.. The 510(k) number is K974401.

When did 4.0MM SIMPLER ONE THREADED DENTAL IMPLANT receive FDA 510(k) clearance?

4.0MM SIMPLER ONE THREADED DENTAL IMPLANT received FDA 510(k) clearance on 1998-02-23, under 510(k) number K974401.

Who is the listed applicant for 4.0MM SIMPLER ONE THREADED DENTAL IMPLANT?

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

What is the FDA product code for 4.0MM SIMPLER ONE THREADED DENTAL IMPLANT?

The FDA product code for 4.0MM SIMPLER ONE THREADED DENTAL IMPLANT 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vancouver Implant Resources, 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.

K9748574.0MM SIMPLER THREADED DENTAL IMPLANTK9748563.25MM SIMPLER THREADED DENTAL IMPLANTK9744044.0MM SIMPLER ONE PUSHIN DENTAL IMPLANTK9744023.25 MM SIMPLER ONE THREADED DENTAL IMPLANTK9744033.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT

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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