Skip to content

Integral Vii 4.9MM Biointegrated Dental Implant System

by Calcitek, Inc.

510(k) K946319

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK946319 Date15 Nov 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Integral Vii 4.9mm Biointegrated Dental Implant System is a root-form endosseous dental implant. It is designed to function as a dental implant system for clinical use.

This device is identified by K946319 and received FDA 510(k) clearance on November 15, 1995. It is manufactured by Calcitek, Inc. and is categorized under the dental product code DZE.

Other devices from Calcitek, Inc.

See all devices from Calcitek, Inc. →

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Integral VII 4.9mm Biointegrated Dental Implant System?

    This device is a root-form endosseous dental implant designed to function as a dental implant system for clinical use.

  • What is the regulatory status of this implant system?

    The Integral VII 4.9mm Biointegrated Dental Implant System received FDA 510(k) clearance on November 15, 1995, under the submission number K946319.

  • How is this device categorized for regulatory purposes?

    The system is categorized under the dental product code DZE, which pertains to endosseous dental implants reviewed by the Dental advisory committee.