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FDA 510(k)

BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM

K-Number: K013383 · 2002-01-10

ApplicantBiomedical Implant Technology, Inc.
Decision Date2002-01-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM 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 2002-01-10 under 510(k) number K013383. 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 BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM?

BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-10. The listed applicant is Biomedical Implant Technology, Inc.. The 510(k) number is K013383.

When did BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2002-01-10, under 510(k) number K013383.

Who is the listed applicant for BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM?

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 BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM?

The FDA product code for BIOHEX ONE-PIECE ONE STAGE 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 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.

K962753KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)

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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