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FDA 510(k)

KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)

K-Number: K962753 · 1997-05-19

ApplicantBiomedical Implant Technology, Inc.
Decision Date1997-05-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS) is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Implant Technology, Inc.. It received FDA 510(k) clearance on 1997-05-19 under 510(k) number K962753. 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 KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)?

KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS) is a medical device that received FDA 510(k) clearance on 1997-05-19. The listed applicant is Biomedical Implant Technology, Inc.. The 510(k) number is K962753.

When did KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS) receive FDA 510(k) clearance?

KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS) received FDA 510(k) clearance on 1997-05-19, under 510(k) number K962753.

Who is the listed applicant for KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)?

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

What is the FDA product code for KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)?

The FDA product code for KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS) 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 Biomedical Implant Technology, 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.

K013383BIOHEX ONE-PIECE ONE STAGE 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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