OSSEOSPEED TM PROFILE SYSTEM

K080156 · Astra Tech AB · DZE · Sep 17, 2008 · Dental

Device Facts

• Record ID: K080156
• Device Name: OSSEOSPEED TM PROFILE SYSTEM
• Applicant: Astra Tech AB
• Product Code: DZE · Dental
• Decision Date: Sep 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsseoSpeed™ Profile is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed Profile is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.

Device Story

OsseoSpeed™ Profile is a self-tapping, threaded, root-formed dental implant; used to restore esthetics and chewing function in edentulous or partially edentulous patients. Device consists of titanium with a microroughened, fluoride-modified surface; features a contoured coronal margin designed to mimic alveolar bone contour. Implanted by dental professionals in clinical settings; supports prosthetic devices. Fluoride-modified surface promotes bone attachment and osseointegration; contoured margin provides esthetic benefit. Device facilitates single-stage or two-stage surgical procedures; allows for immediate loading when primary stability is achieved. Benefits include improved osseointegration, particularly in soft bone, and enhanced esthetic outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium; Surface: Microroughened and fluoride-modified; Design: Self-tapping, threaded, root-formed dental implant with contoured coronal margin. No software or electronic components.

Indications for Use

Indicated for patients requiring replacement of missing teeth in mandible or maxilla; suitable for single or multiple unit applications; applicable for immediate implantation in extraction sites or healed alveolar ridges; indicated for soft bone applications; contraindication: immediate loading in Type IV bone where primary stability is difficult to obtain.

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.

Submission Summary (Full Text)

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## SEP 1 7 2008

## 510(k) Summary

## Astra Tech AB OsseoSpeed™ Profile, A component of the Astra Tech Implant System

### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Astra Tech AB |
|--------------------|-----------------------------|
| | Aminogatan 1, P.O. Box 14 |
| | Mölndal, Sweden SE-431-21 |
| | Telephone: [phone] |
| | Fax: [phone] |

Official Contact:

Christina Lewing

Representative/Consultant:

Linda K. Schulz Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: [phone] Fax: [phone] email: [e-mail] [e-mail]

### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | OsseoSpeed™ Profile System |
|-----------------------------|------------------------------------------------------------------------------|
| Common Name: | dental implant |
| Classification Regulations: | Implant, Endosseous, Root Form,<br>Class II, 21CFR 872.3640: 21 CFR 872.3630 |
| Product Code: | DZE; NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |

#### INTENDED USE

OsseoSpeed™ Profile is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

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The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed Profile is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.

#### DEVICE DESCRIPTION

The OsseoSpeed™ Profile is a self-tapping, threaded, root-formed dental implant, intended for supporting prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. It is made from titanium with a microroughened and fluoride-modified surface, designated OsseoSpeed. It includes a contoured coronal margin that mimics the contour of alveolar bone and is designed to create a more desirable esthetic effect.

### EQUIVALENCE TO MARKETED DEVICE

Astra Tech AB demonstrated that, for the purposes of FDA's regulation of medical devices, the OsseoSpeed™ Profile is substantially equivalent in indications and design principals to the predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings spread and head turned to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 17 2008

Astra Tech AB C/O Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K080156

Trade/Device Name: OsseoSpeed™ Profile System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 5, 2008 Received: September 8, 2008

Dear Ms. Schulz:

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 - Ms. Schulz

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)); please contact the Division of Surveillance Systems at 240-276-3464. 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.

Kromwell Herkimer foey

Chiu S. Lin. Ph. D Division 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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510(k) Premarket Notification

OsseoSpeed™ Profile

# Indications for Use

510(k) Number (if known): K080156

Device Name: OsseoSpeed™ Profile System

Indications for Use:

OsseoSpeed™ Profile is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed Profile is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Susan Kupre |
|----------------|----------------------------------------------|
| | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital |
| | Infection Control, Dental Devices |
| 510(k) Number: | K080156 |