PITT-EASY DENTAL IMPLANT SYSTEM

K053242 · Innova Life Sciences Corp. · DZE · Jan 6, 2006 · Dental

Device Facts

• Record ID: K053242
• Device Name: PITT-EASY DENTAL IMPLANT SYSTEM
• Applicant: Innova Life Sciences Corp.
• Product Code: DZE · Dental
• Decision Date: Jan 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pitt-Easy™ Dental Implant System is indicated for use in the upper or lower jaw arches to provide support for a dental prosthesis.

Device Story

Endosseous dental implant system; provides support for dental prostheses in upper or lower jaw arches. Device consists of implant and abutment components. Implant lengths range from 8 to 24 mm; diameters similar to predicate systems. Used by dental professionals in clinical settings. Functions as mechanical anchor for prosthetic restoration; facilitates osseointegration. Benefits patient by restoring dental function and aesthetics.

Clinical Evidence

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

Technological Characteristics

Endosseous dental implant and abutment system. Features internal connection. Implant lengths: 8-24 mm. Diameters consistent with predicate devices. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring endosseous dental implants in upper or lower jaw arches to support 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

• Entegra™ Dental Implant System (K961385)
• Bicortical® Screw Dental Implant System (K983120)

Submission Summary (Full Text)

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#### JAN 6 2006

K05-3242

### 510(K) SUMMARY FOR THE INNOVA LIFESCIENCES CORPORATION
S CORPORATION DACUENDENTAL IMPLANT SYSTEM PITT-EASY™ DENTAL IMPLANT SYSTEM

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

Innova LifeSciences Corporation 522 University Avenue, Suite 1200 Toronto, Ontario M5G 1W7 Canada

| Contact: | Michael A. Kehoe<br>Managing Director, Oraltronics Dental Implant Technology GmbH<br>President, Innova LifeSciences Corporation |
|------------|---------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Facsimile: | [phone] |

#### Date Prepared

November 17, 2005

### Name of the Device

Pitt-Easy™ Dental Implant System

### Common or Usual Name

Endosseous Implant and Abutment

### Classification Name

Endosseous Implant (DZE); Endosseous Dental Implant Abutment

(NHA)

#### Predicate Devices

Entegra™ Dental Implant System (K961385) and Bicortical® Screw Dental Implant System (K983120).

#### Intended Use

The Pitt-Easy™ Dental Implant System 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 those of the previously cleared Entegra™ Dental Implant System (K961385) and of the previously croation of System (K983120).

### Technological Characteristics

The technological characteristics of the modified Pitt-Easy™ Dental Implant System also are identical to those of the previously cleared Entegra™ Implant System also are facilitied to also of an internal connection and the Dental Implant System, except for the ass of the Pitt-Easy Implant (8 to 24 addition of all actueets surface. The longe of lengths of the previously cleared
mm in 2 mm increments) are within the range of lengths of the best (25 mm in 2 mm nicrements) are within the rangers of the Pitt-Easy Implant (3.25,
Entegra and Bicortical Implants. The diameters of the Pitt-Easy Image and Entegra and Dicorned Inplants. Frinilar to the range of previously cleared diameters.

### Summary Basis for the Finding of Substantial Equivalence

The minor modifications to the design of the Entegra™ Dental Implant System (K961385) and Bicortical® Screw Dental Implant System (K983120) do not System (1.001.000) and Dictrically we or its fundamental scientific technology. alter the implant s multations for use to tiselly equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, with three curved lines representing the bird's body and tail feathers.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 6 2006

Innova LifeSciences Corporation C/O Mr. Howard M. Holstein Hogan & Hartson L.L.P. 555 13th Street N.W. Washington, DC 20004

Re: K053242

Trade/Device Name: Pitt-Easy™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 27, 2005 Received: December 27, 2005

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, thereforc, 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 Lederal 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. or the ret of any I 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 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.

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), rs you donto 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/industry/support/index.html.

Sincerely vours.

Sigite y. Michael md.

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: Pitt-Easy™ 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 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 C.F.R. 807 Subpart C)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pearson

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