HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT

K040714 · Innova Corp. · DZE · Apr 9, 2004 · Dental

Device Facts

• Record ID: K040714
• Device Name: HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT
• Applicant: Innova Corp.
• Product Code: DZE · Dental
• Decision Date: Apr 9, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endopore Implant is indicated for use in the upper or lower jaw arches to provide support for a dental prosthesis.

Device Story

The Hybrid Endopore Endosseous Dental Implant System is a dental implant designed for placement in the upper or lower jaw to support dental prostheses. It functions as an endosseous implant, providing a stable foundation for restorative dentistry. The device is a modification of the previously cleared Endopore system, featuring the addition of three self-tapping threads in the coronal region to facilitate direct placement via a threaded-screw design. It is intended for use by dental professionals in a clinical setting. The device provides mechanical support for prosthetic devices, benefiting patients requiring tooth replacement by anchoring the prosthesis to the jawbone.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics compared to predicate devices.

Technological Characteristics

Endosseous dental implant; features three self-tapping threads in the coronal region; threaded-screw design. Dimensions: 9.5 mm and 11 mm length x 4.0 mm diameter; 7.5 mm and 9.5 mm length x 5.0 mm diameter. Materials and fundamental technology are identical to previously cleared Endopore implants.

Indications for Use

Indicated for use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.

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

• Endopore Endosseous Dental Implant System 4.1 mm diameter (K926354)
• Endopore Endosseous Dental Implant System 5.0 mm diameter (K971196)
• Endopore Endosseous Dental Implant System 5 mm long x 5.0 mm diameter (K032140)

Submission Summary (Full Text)

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K040714

## 510(K) SUMMARY FOR THE INNOVA CORPORATION HYBRID ENDOPORE IMPLANT

# APR - 9 2004

## Submitter's Name, Address, Telephone Number, And Contact Person

Innova LifeSciences Corporation 525 University Avenue, Suite 777 Toronto, Ontario M5G 2L3 Canada

Contact: Michael A. Kehoe, President Telephone: [phone] Facsimile: [phone]

#### Date Prepared

February 25, 2004

#### Name of the Device

Hybrid Endopore® Endosseous Dental Implant System

#### Common or Usual Name

Endosseous Implant

## Classification Name

Endosscous Implant (DZE)

#### Predicate Devices

Endopore® Endosseous Dental Implant System in 4.1 mm diameter

(K926354) and 5.0 mm diameter (K971196); 5 mm long x 5.0 mm diameter

Endopore Endosseous Dental Implant System (K032140).

#### Intended Use

The Endopore Implant is indicated for use in the upper or lower jaw

arches to provide support for a dental prosthesis.

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## Principles of Operation

The principles of operation of the modified device are identical to the previously cleared Endopore Implant System except for the direct placement of the implant in the manner of a threaded-screw design.

## Technological Characteristics

The technological characteristics of the modified Hybrid Endopore Implant also are identical to the predicates, except for the addition of three selftapping threads in the coronal region of the implant. The dimensions of the modified Hybrid Endopore Implant, 9.5 mm and 11 mm in length x 4.0 mm diameter; and 7.5 mm and 9.5 mm in length x 5.0 mm diameter, are very similar to the dimensions of previously cleared Endopore implants.

## Summary Basis for the Finding of Substantial Equivalence

The minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology. Therefore, the modified device is substantially equivalent to the predicates.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 2004

Innova LifeSciences Corporation Mr.Howard M. Holstein C/O Mr. Hogan & Hartson L.L.P. 555 Thirteenth Street N.W. Washington D.C. 20004

Re: K040714

Trade/Device Name: Hybrid Endopore® Endosseous Dental Implant System Regulation Number: 872. 3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: March 17, 2004 Received: March 18, 2004

Dear Mr. Holstein:

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 application (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 such 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. Holstein

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); good manufacturing practice recuirements 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely vours.

f. H. Welch

for,

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Hybrid Endopore® Endosscous Dental Implant System

Indications For Use:

For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dr. Robert Sheetz, DDS for Dr. S. Kumar

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number:

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