OSSEOSPEED 4.0S-6MM, MODEL 24619

K063779 · Astra Tech, Inc. · DZE · Apr 27, 2007 · Dental

Device Facts

• Record ID: K063779
• Device Name: OSSEOSPEED 4.0S-6MM, MODEL 24619
• Applicant: Astra Tech, Inc.
• Product Code: DZE · Dental
• Decision Date: Apr 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OsseoSpeed™ 4.0S - 6 mm is intended to be used to replace missing masticatory functional units (tecth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained. 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 after implantation where immediate implant stability may be obtained. 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 4.0S - 6 mm 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

Threaded, root-form dental implant; titanium construction; micro-roughened, fluoride-modified surface (OsseoSpeed). Used by dental surgeons to replace missing teeth in edentulous or partially edentulous patients; supports prosthetic devices to restore esthetics and chewing function. Implanted into mandible or maxilla; provides substrate for bone attachment and osseointegration. Designed for use in soft bone; supports immediate loading in specific clinical scenarios where stability is achieved. Immediate loading of single tooth restorations is not recommended for this specific 6 mm length.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Titanium dental implant; threaded, root-form geometry; micro-roughened, fluoride-modified surface. Dimensions: 4.0S diameter, 6 mm length. Class II device (21 CFR 872.3640).

Indications for Use

Indicated for patients requiring replacement of missing teeth in mandible or maxilla. Suitable for single or multiple unit applications, single or two-stage surgical procedures, and immediate implantation in extraction sites or healed alveolar ridges. Especially indicated for soft bone applications. Contraindicated for immediate loading of single tooth restorations in Type IV bone.

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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510(k) Summary

OsseoSpeed™ 4.0S - 6 mm

K063779

# 510(k) Summary

# Astra Tech, Inc. OsseoSpeed™ 4.0S - 6 mm

APR 2 7 2007

## ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Astra Tech, Inc.<br>890 Winter Street, Suite 310<br>Waltham, MA 02451<br>Telephone [phone]<br>Fax [phone] |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Scott A. Root |
| Representative/Consultant: | Floyd G. Larson<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200<br>San Diego, CA 92130<br>Telephone [phone]<br>Fax [phone]<br>email: [e-mail] |

#### DEVICE NAME

| Classification Name: | Implant, Endosseous, Root Form |
|-------------------------|--------------------------------|
| Trade/Proprietary Name: | OsseoSpeed 4.0S - 6 mm |
| Common Name: | dental implant |

#### DEVICE CLASSIFICATION

Implant, Endosseous, Root-Form is classified as Class II (21 CFR 872.3640). The product code is DZE. This device is classified by the Dental Products Branch.

## INTENDED USE

The OsseoSpeed™ 4.0S - 6 mm is intended to be used to replace missing masticatory functional units (tecth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained. 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

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situations. When a one-stage surgical approach is applied, the implant may be immediately loaded after implantation where immediate implant stability may be obtained.

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 4.0S - 6 mm 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

#### Design and Material

OsseoSpeed 4.0S - 6 mm is a threaded, root-form dental implant intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. It is made from titanium with a micro-roughened and fluoride-modified surface, designated OsseoSpeed.

## EQUIVALENCE TO MARKETED DEVICE

Astra Tech, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the OsseoSpeed M 4.0S - 6 mm is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment 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 stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Astra Tech, Incorporated C/O Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

APR 2 7 2007

Re: K063779

Trade/Device Name: OsseoSpeed 4.0S -- 6mm Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulation Class: II Product Code: DZE Dated: March 7, 2007 Received: March 9, 2007

Dear Mr. Larson:

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 invlude 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 ta 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Larson

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/industry/support/index.html.

Sincerely yours,

Chiu Lien, 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): K063779

OsseoSpeed™ 4.0S - 6 mm, Device Name: a component of the Astra Tech Implant System

Indications for Use:

The OsseoSpeed™ system is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained. 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 after implantation where immediate implant stability may be obtained.

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 implants are 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. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed™ 4.0S - 6 mm implant.

Prescription Use X (Part 21 CFR 801 Subpart D)

O(k) Number:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suor Runn

(Sign-Off)
ion of Anesthesiology, General Hospital,
cuon Control, Dental Devices