DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET

K970572 · Implant Integration Systems, Inc. · DZE · Jan 16, 1998 · Dental

Device Facts

• Record ID: K970572
• Device Name: DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET
• Applicant: Implant Integration Systems, Inc.
• Product Code: DZE · Dental
• Decision Date: Jan 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

This product is designed for use in the placement of the “Dual Integrator” Dental Implant (K944225). The Parallel Pin is used to insure correct vertical placement of the implant. The Depth Gauge is used to measure the depth of surgical site, while the Surgical Ratchet is used to screw the “Dual Integrator” Dental Implant into the surgical site. These products along with the “Dual Integrator” Dental Implant make up the total system of tooth replacement by Implant Integration Systems.

Device Story

The “Dual Integrator” Dental Implant Accessories consist of a parallel pin, depth gauge, and surgical ratchet. These manual surgical instruments are used by clinicians during dental implant surgery. The parallel pin assists in verifying correct vertical implant placement; the depth gauge measures the surgical site depth; the surgical ratchet provides the mechanical torque required to screw the implant into the prepared site. These tools are integral to the “Dual Integrator” system for tooth replacement. They function as standard manual surgical instrumentation to facilitate accurate implant positioning and installation.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Manual surgical instruments constructed of stainless steel. Includes parallel pins, depth gauges, and surgical ratchets. Designed for use with the “Dual Integrator” Dental Implant system.

Indications for Use

Indicated for use in the surgical placement of the “Dual Integrator” Dental Implant for tooth replacement procedures.

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 1208 (K904707)
• Impla-Med, Inc. Stainless Steel Instruments (K902911)
• Minimatic Implant Tech. DG-1109 Depth Gage (K903115)
• Implant Innovations Int. Innovative Implants and Cover Screws (K874590)

Submission Summary (Full Text)

{0}

JAN 16 1996

# Implant Integration Systems, Inc.

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

K970572

Summary of Safety and Effectiveness Information

The “Dual Integrator” Parallel Pin, Depth Gage, and Surgical Ratchet are all intended to be used with the Implant Integration Systems “Dual Integrator” Dental Implant (K944225).

This product is similar in design, composition (stainless steel) and function to the Minimatic Implant Tech. BC 1208 (K904707), the Impla-Med, Inc. Stainless Steel Instruments (K902911), the Minimatic Implant Tech. DG-1109 Depth Gage (K903115), the Implant Innovations Int. Innovative Implants and Cover Screws (K874590), as well as, parallel pins, depth gauges and surgical ratchets from any other implant system.


2-11-97

Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Corey D. Hanosh
Sales Manager
Implant Integration System, Incorporated
6161 Clark Road, Suite 8
Paradise, California 95969

JAN 16 1998

Re: K970572
Trade Name: "Dual Integrator" Dental Implant Accessories
Parallel Pin
Regulatory Class: III
Product Code: DZE
Dated: February 11, 1997
Received: February 14, 1997

Dear Mr. Hanosh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Hanosh

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# Implant Integration Systems, Inc.

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

## Indications For Use

This product is designed for use in the placement of the “Dual Integrator” Dental Implant (K944225).

The Parallel Pin is used to insure correct vertical placement of the implant. The Depth Gauge is used to measure the depth of surgical site, while the Surgical Ratchet is used to screw the “Dual Integrator” Dental Implant into the surgical site.

These products along with the “Dual Integrator” Dental Implant make up the total system of tooth replacement by Implant Integration Systems.

Sincerely,


(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number **K970572**

Prescription Use
(Per 21 CFR 801.109)