CORTEX DENTAL IMPLANT SYSTEM

K090709 · Cortex Dental Implants Industries , Ltd. · DZE · Jul 7, 2009 · Dental

Device Facts

• Record ID: K090709
• Device Name: CORTEX DENTAL IMPLANT SYSTEM
• Applicant: Cortex Dental Implants Industries , Ltd.
• Product Code: DZE · Dental
• Decision Date: Jul 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cortex Dental Implant System is indicated for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.

Device Story

Cortex Dental Implant System comprises dental implants, abutments, prosthetic/surgical components, and instruments. Used by dental professionals in surgical and restorative applications for upper/lower jaw bone placement. Provides support for artificial teeth to restore chewing function. System supports single or multiple tooth applications. Mechanical strength verified via worst-case configuration testing. Surface treatment utilizes acid process compliant with ASTM B 600-91; SEM-EDS confirms surface morphology and cleanliness from residuals. Benefits include reliable prosthetic support and restoration of oral function.

Clinical Evidence

Bench testing only. Mechanical strength testing performed per FDA Class II Special Controls Guidance for Root-form Endosseous Dental Implants. SEM-EDS analysis validated surface morphology and cleaning processes (removal of alumina residuals/detergents) per ASTM B 600-91 guidelines.

Technological Characteristics

Endosseous dental implant system. Materials processed via acid treatment per ASTM B 600-91. Surface morphology verified by SEM-EDS. System includes implants, abutments, and surgical instruments. No software or electronic components.

Indications for Use

Indicated for patients requiring surgical (single or two-stage) and restorative dental procedures for placement in the upper or lower jaw bone to support prosthetic devices (artificial teeth) and restore chewing function; applicable for single or multiple tooth replacement.

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

• MIS Dental Implant System (Seven implant series) (K040807)
• Uno - One Piece Screw-Type Dental Implant (K080162)
• Legacy System Dental Implants (K030007)

Submission Summary (Full Text)

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K0910709

# SECTION 5: 510(k) Summary

### Submitter

Cortex Dental Implants Industries Ltd. Nof Bldg. Migdal Tefen Industrial Zone P.O.Box 49 24959 ISRAEL Tel: [phone] Fax: [phone] e-mail: [e-mail] Web Site: www.cortex-dental.com

### Contact Person

Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187, ISRAEL Tel: [phone] Fax: [phone] E-mail: [e-mail]

### Date Prepared

March, 2009

### Device Information

Trade Name: Cortex Dental Implant system Product Code: DZE, NHA Regulation Name: Endosseous dental implant Regulation Number: 872.3640 Device Class: Class II Review Panel: Dental

### Devices to which substantial equivalence is claimed:

| 510(k) No. | Trade or propriety name | Manufacturer |
|------------|----------------------------------------------------------------------|---------------------------------|
| K040807 | MIS Dental Implant System<br>(specifically the Seven implant series) | MIS - Implant Technologies Ltd. |
| K080162 | Uno - One Piece Screw-Type<br>Dental Implant | MIS - Implant Technologies Ltd. |
| K030007 | Legacy System Dental<br>Implants | Implant Direct LLC |

Image /page/0/Picture/13 description: The image shows the word "CORTEX" in a dotted font. Below the word "CORTEX" is the phrase "dental implants" in a smaller, dotted font. The text appears to be a logo or brand name. The image is black and white.

## JUL - 7 2009

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### Device Description

The Cortex Dental Implant System includes an integral array of devices comprising mainly of dental implants, abutments, additional prosthetic and surgical components, post surgical components, and surgical instruments.

### Intended Use

The Cortex Dental Implant System is indicated for use in surgical (singlestage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.

### Performance

Mechanical strength testing of the implant system was performed according to FDA "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"

The specimen tested represents the most vulnerable system configuration (worst case). Test results show that the implant/abutment combination is highly resistant

The Acid Treatment Process was designed in compliance with the guidelines of ASTM B 600-91.

SEM-EDS results demonstrated how the process saves the morphology of the surface. Process validation also verified that that implant surface is indeed cleaned from all alumina residuals and washing detergents used during the machining and alumina blasting.

### Conclusion

The Cortex Dental Implant System, subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or safety risks to patients when used as intended.

The Cortex Dental Implant System has the same intended use and fundamental scientific technology as its predicate devices - the MIS Dental Implant System (specifically the Seven implant series - K040807) and Uno -One Piece Screw-Type Dental Implant (K080162) by MIS - Implant Technologies Ltd .; and the Legacy System Dental Implants by Implant Direct LLC (K030007).

We therefore believe that the Cortex Dental Implant System and its predicate devices are substantially equivalent

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cortex Dental Implants Industries, Limited Mr. Benny Arazy Chief Executive Officer and President Arazy Group-Medical Device Consultants Industrial Park 13 Mizpe Aviv, M.P. Misgav ISRAEL 20187

NOV 28 2011

Re: K090709

Trade/Device Name: Cortex Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated (Date on orig SE ltr): July 7, 2009 Received (Date on orig SE Itr): July 1, 2009

Dear Mr. Arazy:

This letter corrects our substantially equivalent letter of July 7, 2009.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Arazy

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

h for.

Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# SECTION 4: Indications for Use

510(k) Number:

510(k) Number: K090709

Device Name:

Cortex Dental Implant System

Intended Use:

The Cortex Dental Implant System is indicated for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

Kein Harley for YPR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

209070 510(k) Number: