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FDA 510(k)

IMPLA-MED IMPLANT SYSTEM

K-Number: K892124 · 1989-10-20

ApplicantImpla-Med
Decision Date1989-10-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPLA-MED IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Impla-Med. It received FDA 510(k) clearance on 1989-10-20 under 510(k) number K892124. 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 IMPLA-MED IMPLANT SYSTEM?

IMPLA-MED IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1989-10-20. The listed applicant is Impla-Med. The 510(k) number is K892124.

When did IMPLA-MED IMPLANT SYSTEM receive FDA 510(k) clearance?

IMPLA-MED IMPLANT SYSTEM received FDA 510(k) clearance on 1989-10-20, under 510(k) number K892124.

Who is the listed applicant for IMPLA-MED IMPLANT SYSTEM?

The FDA 510(k) record lists Impla-Med as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLA-MED IMPLANT SYSTEM?

The FDA product code for IMPLA-MED 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.

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 Impla-Med 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.

K921854IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MMK902911TITANIUM/STAINLESS STEEL INSTRUMENTSK902158TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMPK900061IMPLA-MED TITANIUM, IMPLANT DEVICES

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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