SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM

K043190 · Innova Life Sciences Corp. · NHA · Dec 14, 2004 · Dental

Device Facts

• Record ID: K043190
• Device Name: SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
• Applicant: Innova Life Sciences Corp.
• Product Code: NHA · Dental
• Decision Date: Dec 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• 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

Scalloped Endopore Endosseous Dental Implant System; endosseous dental implant for jaw arch support of dental prostheses. Device features scalloped coronal margin and 1.5 mm lightly-acid etched region apical to smooth coronal region. Implant dimensions 10.5 mm length x 4.8 mm diameter. Used by dental professionals in clinical settings to anchor prosthetic devices. Principle of operation identical to predicate Endopore systems, utilizing internal connection for abutment attachment.

Clinical Evidence

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

Technological Characteristics

Endosseous dental implant; scalloped coronal margin; 1.5 mm lightly-acid etched region apical to smooth coronal region; dimensions 10.5 mm length x 4.8 mm diameter; internal connection for abutment attachment.

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 abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

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

### DEC 1 4 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

November 12, 2004

#### Name of the Device

Scalloped Endopore® Endosseous Dental Implant System

#### Common or Usual Name

Endosseous Implant and Abutment

#### Classification Name

Endosseous Implant (DZE) ; Endosseous Dental Implant Abutment (NHA)

#### 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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K043190

The principles of operation of the modified device are identical to the previously cleared Endopore Implant System except for the attachment of abutments via an internal connection.

#### Technological Characteristics

The technological characteristics of the modified Scalloped Endopore Implant also are identical to the predicates, except for the addition of a 1.5 mm lightly-acid etched region immediately apical to the smooth coronal region, and a scalloped coronal margin. The dimensions of the modified Scalloped Endopore Implant, 10.5 mm in length x 4.8 mm diameter, are within the range of 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles three abstract shapes stacked on top of each other, possibly representing human figures or abstract forms.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 4 2004

Mr. Howard M. Holstein Innova LifeSciences Corporation 555 Thirteenth Street, NW Washington, DC 20004-1109

Re: K043190

Trade/Device Name: Scalloped Endopore Endosseous Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: December 10, 2004 Received: December 10, 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 requirements as set forth in the quality systems (OS) 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 yours,

Chiu Lin, Ph.D.

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): K (H3190

Device Name: Scalloped Endopore® Endosseous 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)

Suoer Rumm

(Division Sign-Off)
Division of Anesthesiology, General Hospital.
Division of Anesthesiology, Gental Devices Division of Anesthesion of Anesther Devices

510(k) Number:*_*_

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