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FDA 510(k)

INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM

K-Number: K943604 · 1996-02-08

ApplicantCalcitek, Inc.
Decision Date1996-02-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Calcitek, Inc.. It received FDA 510(k) clearance on 1996-02-08 under 510(k) number K943604. 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 INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM?

INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-08. The listed applicant is Calcitek, Inc.. The 510(k) number is K943604.

When did INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1996-02-08, under 510(k) number K943604.

Who is the listed applicant for INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM?

The FDA product code for INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM is DZE.

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Other records listing Calcitek, 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.

K962576SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEMK962106SPLINE DENTAL IMPLANT SYSTEMSK9556195.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMSK960021CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMSK946345INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEMK946319INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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