Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM

K-Number: K944327 · 1995-05-16

ApplicantCalcitek, Inc.
Decision Date1995-05-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTEGRAL VI 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 1995-05-16 under 510(k) number K944327. 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 VI BIOINTEGRATED DENTAL IMPLANT SYSTEM?

INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-05-16. The listed applicant is Calcitek, Inc.. The 510(k) number is K944327.

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

INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1995-05-16, under 510(k) number K944327.

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

The FDA product code for INTEGRAL VI BIOINTEGRATED 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.

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 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 SYSTEMSK943604INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEMK946345INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM

View all 21 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

View on FDA Database →

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

↑