DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES

K962610 · Implant Integration Systems, Inc. · DZE · Oct 18, 1996 · Dental

Device Facts

• Record ID: K962610
• Device Name: DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES
• Applicant: Implant Integration Systems, Inc.
• Product Code: DZE · Dental
• Decision Date: Oct 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

The “Dual Integrator” Healing Cap, Implant Carrier Assembly, and Activator Pin Driver are all intended to be used with the Implant Integration Systems “Dual Integrator” Dental Implant (K944225).

Device Story

System components include Healing Cap, Implant Carrier Assembly, and Activator Pin Driver; used in conjunction with Dual Integrator Dental Implant. Components facilitate healing and implant placement. Used in clinical dental settings by dental professionals. Materials include Pure-Ti CP-3, Ti Alloy CP-4, and stainless steel. Device provides mechanical support and interface during dental implant integration.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Pure-Ti CP-3, Ti Alloy CP-4, stainless steel. Components: Healing Cap, Implant Carrier Assembly, Activator Pin Driver. Mechanical interface for dental implant system.

Indications for Use

Indicated for use in dental implant procedures as components for the Implant Integration Systems “Dual Integrator” Dental Implant system.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Minimatic Implant Tech. BC 1213 Healing Screw (K904709)
• Dental Imaging Assoc. Dia Healing Cap (K902434)
• Minimatic Implant Tech. HS-1113 Healing Screw (K903062)
• Implant Innovations Int. Innovative Implants and Cover Screws (K874590)

Submission Summary (Full Text)

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196 2010

# Implant Integration Systems, Inc.

6161 Clark Road, Suite 8 • Paradise, CA 95969 USA • [phone] • Fax: [phone]

Summary of Safety and Effectiveness Information

OCT 18 1996

The “Dual Integrator” Healing Cap, Implant Carrier Assembly, and Activator Pin Driver are all intended to be used with the Implant Integration Systems “Dual Integrator” Dental Implant (K944225).

This product is similar in design, composition (Pure-Ti CP-3, Ti Alloy CP-4, and stainless steel) and function to the Minimatic Implant Tech. BC 1213 Healing Screw (K904709), the Dental Imaging Assoc. Dia Healing Cap (K902434), the Minimatic Implant Tech. HS-1113 Healing Screw (K903062), the Implant Innovations Int. Innovative Implants and Cover Screws (K874590), as well as, healing screws/caps and tools from any other implant system.


7-1-96

Date