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FDA 510(k)

DUAL INTEGRATOR DENTAL IMPLANT

K-Number: K944225 · 1995-09-27

ApplicantImplant Integration Systems, Inc.
Decision Date1995-09-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DUAL INTEGRATOR DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Implant Integration Systems, Inc.. It received FDA 510(k) clearance on 1995-09-27 under 510(k) number K944225. 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 DUAL INTEGRATOR DENTAL IMPLANT?

DUAL INTEGRATOR DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1995-09-27. The listed applicant is Implant Integration Systems, Inc.. The 510(k) number is K944225.

When did DUAL INTEGRATOR DENTAL IMPLANT receive FDA 510(k) clearance?

DUAL INTEGRATOR DENTAL IMPLANT received FDA 510(k) clearance on 1995-09-27, under 510(k) number K944225.

Who is the listed applicant for DUAL INTEGRATOR DENTAL IMPLANT?

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

What is the FDA product code for DUAL INTEGRATOR DENTAL IMPLANT?

The FDA product code for DUAL INTEGRATOR 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 Implant Integration Systems, 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.

K970572DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHETK962610DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIESK962394IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS

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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