DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT

K070184 · Ospol AB · DZE · Mar 24, 2008 · Dental

Device Facts

• Record ID: K070184
• Device Name: DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT
• Applicant: Ospol AB
• Product Code: DZE · Dental
• Decision Date: Mar 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ospol AB, Ospol Dental Implant System is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

Device Story

Ospol Dental Implant System consists of endosseous implants (4.0 mm diameter, 8.0-15.0 mm length) and associated abutments (standard and anatomic, including healing, cover, and abutment screws). Device is surgically placed into the bone of the upper or lower jaw by a dental professional. Acts as permanent anchorage for prosthetic devices to restore masticatory function. System utilizes commercially pure titanium. Performance is established via comparison to predicate devices regarding material, dimensions, and intended use.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and dimensional comparison to predicate devices.

Technological Characteristics

Commercially pure titanium construction. System includes implants (4.0 mm diameter, 8.0-15.0 mm length) and abutments. Mechanical testing performed per FDA guidance 'Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments' (May 12, 2004).

Indications for Use

Indicated for patients requiring permanent anchorage for prosthetic devices in the upper or lower jaw to restore chewing function.

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

• Nobel Biocare, TiUnite Endosseous Implants (K050705)
• Astra Tech, Fixture Micro Thread™ Osseo Speed™ (K053384)

Submission Summary (Full Text)

{0}------------------------------------------------

# 4070184

# SECTION 2. SUMMARY AND CERTIFICATION

MAR 2 4 2008

# A. 510(k) SUMMARY

## Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Ospol AB summary for the Ospol Dental Implant System .

| SUBMITTER'S NAME: | Ospol AB |
|---------------------|-------------------------------------|
| ADDRESS: | Jorgen Kocksgatan 9, SE211 20 Malme |
| CONTACT PERSON: | Lennart Carlson |
| TELEPHONE NUMBER: | [phone] |
| FAX NUMBER: | [phone] |
| DATE OF SUBMISSION: | January 10, 2007 |

#### 1. Identification of device

Proprietary Name: Endosseous Implant and Abutment Common Name: Ospol Dental Implant System Classification Status: Class II per regulations 872.3640 (implant) and 872.3630 (abutment) Product Codes: DZE (implant) and NHA (abutment)

#### 2. Equivalent devices

Ospol AB believes the Ospol Dental Implant System is substantially equivalent to K050705 Nobel Biocare, TiUnite Endosseous Implants K053384 Astra Tech, Fixture Micro Thread™ Osseo Speed™

#### Description of the Device 3.

The Ospol Dental Implant System consists of 4 implants, diameter 4,0 mm, and length from 8,0 to 15,0 mm, 2 standard Abutments (high and low) and 2 Anatomic Abutments (high and low) including healing abutments, cover and abutment screws.

- 4. Intended use
The Ospol AB, Ospol Dental Implant System is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

#### 5. Technological characteristics, comparison to predicate device.

Like the predicate devices, the Ospol Dental Implant System is intended to restore masticator function.

8

{1}------------------------------------------------

### Comparison table

| Characteristic | Ospol Dental Implant<br>System | Nobel Biocare TiUnite<br>Implants | Astra Tech Fixture<br>Micro<br>OsseoSpeed<br>Thread | Subst.<br>equivalent |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indication for<br>use | Surgical placement into<br>upper lower jaw arches<br>as permanent support<br>for prosthetic<br>attachment, to restore<br>masticatory function. | Surgical placement into<br>upper lower jaw arches as<br>permanent support for<br>prosthetic devices in order<br>to restore patient esthetics<br>and chewing function | Replace missing<br>masticatory functional<br>units (teeth) in single or<br>multiple unit<br>applications within the<br>mandible or maxilla<br>where immediate<br>implant stability may be<br>obtained. | Yes |
| Dimensions | Diam 4,0 length 8 - 15<br>mm | Diam 3,3 - 6,0 mm<br>Length 6 - 18 mm | Diam. 4.0 length 8 - 19<br>mm | Yes |
| Material | Commercially pure<br>Titanium | Titanium | Titanium | Yes |
| 510(k) | No number vet | K050705 | K053384 | |

#### 6. Discussion of performance testing.

Mechanical testing requested for Screw-type Endosseous Implants are described in the Guideline "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, dated May 12, 2004.

Ospol AB, Ospol Dental Implant System is substantially equivalent to Nobel Biocare TiUnite and the Astra Tech Fixture Micro Thread™ Osseo Speed™ in material, dimensions, and indication for use why we have come to the conclusion that further testing will not raise new issues of safety and efficacy.

#### 7. Conclusion

Based on comparison to the predicate device, the Ospol Dental Implant System is substantially equivalent to previously cleared predicate systems and presents no new concerns about safety and effectiveness.

{2}------------------------------------------------

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 stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2008

Mr. Lennart Carlsson R&D Manager Ospol AB Jorgen Kocksgatan 9 SE-211 20 Malmo SWEDEN

Re: K070184

Trade/Device Name: Ospol AB, Ospol Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 7, 2008 Received: March 10, 2008

Dear Mr. Carlsson:

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.

{3}------------------------------------------------

### Page 2 - Mr. Carlsson

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 (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/industry/support/index.html.

Sincerely yours,

Suste y. Mckin and.

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

{4}------------------------------------------------

Page 1 of 1

## B. INDICATIONS FOR USE

KO 70184 510(k) Number

Device Name: Ospol AB, Ospol Dental Implant System .

Indications for Use:

The Ospol AB, Ospol Dental Implant System is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use

Rspptz 003 for Dr. Susan Runner

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K070184