FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM

K053384 · Astra Tech, Inc. · DZE · Mar 24, 2006 · Dental

Device Facts

• Record ID: K053384
• Device Name: FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM
• Applicant: Astra Tech, Inc.
• Product Code: DZE · Dental
• Decision Date: Mar 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fixture MicroThread™ OsseoSpeed™ 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. Fixture MicroThread OsseoSpeed 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

Fixture MicroThread OsseoSpeed is a threaded, root-formed dental implant; constructed from titanium with a micro-roughened, fluoride-modified surface. Designed to support prosthetic devices for restoring esthetics and chewing function in edentulous or partially dentate patients. Implant features straight or tapered neck contours; available in various diameters and lengths; utilizes screw-retained abutments. Used by dental clinicians in surgical settings. Fluoride-modified surface promotes bone attachment and osseointegration; facilitates use in soft bone and immediate loading protocols. Clinical benefit includes improved early bone formation and increased bone-to-implant strength compared to standard surfaces.

Clinical Evidence

Pre-clinical and clinical data provided. Evidence demonstrates that the fluoride-modified surface promotes increased and more rapid bone formation compared to the TiOblast surface and maintains increased bone-to-implant strength over time. Data supports the use of the device in soft bone and immediate loading protocols.

Technological Characteristics

Threaded, root-formed dental implant; material: titanium; surface: micro-roughened and fluoride-modified. Available in straight or tapered neck contours with various diameters and lengths. Abutments are screw-retained. No software or electronic components.

Indications for Use

Indicated for edentulous or partially dentate patients requiring replacement of missing teeth in mandible or maxilla. Suitable for single or multiple unit applications, immediate or delayed implantation, and single or two-stage surgical procedures. Especially indicated for soft bone applications. Contraindicated for immediate loading of single tooth restorations in Type IV bone where initial 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.

Predicate Devices

• Fixture OsseoSpeed

Reference Devices

• TiUnite implant

Submission Summary (Full Text)

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510(k) Summary

| K053384 | 510(k) Summary |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ADMINISTRATIVE INFORMATION | |
| Manufacturer Name: | Astra Tech, Inc.<br>890 Winter Street, Suite 310<br>Waltham, MA 02451-1493<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] |
| DEVICE NAME | |
| Classification Names: | Implant, Dental, Root-Form |
| Trade/Proprietary Name: | Fixture MicroThread™ OsseoSpeed™, a component of<br>the Astra Tech Implant System |
| Common Name: | Dental Implant |

# ESTABLISHMENT REGISTRATION NUMBER

Astra Tech, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 1222802. The owner/operator number for Astra Tech, Inc. is 9003608.

### DEVICE CLASSIFICATION

FDA has classified endosseous dental implants as Class II devices (21 CFR 872.3640 according to revision 69 FR 26307, May 12, 2004). The product code for "Implant, Dental, Root-Form" is DZE. Endosseous dental implants and abutments are reviewed by the Dental Products Panel.

# INTENDED USE

Fixture MicroThread™ OsseoSpeed™ 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

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510(k) Summary

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. Fixture MicroThread OsseoSpeed 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

Fixture MicroThread OsseoSpeed is a threaded, root-formed dental implant intended for supporting prosthetic devices in edentulous or partially dentate patients to restore their esthetics and chewing function. Fixture MicroThread OsseoSpeed is made from titanium with a micro-roughened and fluoride-modified surface, designated OsseoSpeed.

The implant is available with a straight or tapered contour at the implant neck and comes in different diameters and lengths. The abutments are screw-retained.

# EQUIVALENCE TO MARKETED PRODUCT

The components provided for in this submission are physically equivalent in material, design and surface characteristics to those previously cleared. This submission clarifies the intended use and indications for Fixture MicroThread Osseospeed.

Basis of substantial equivalence:

Fixture MicroThread OsseoSpeed in this application is substantially equivalent to the currently marketed Fixture OsseoSpeed in intended use, material, design and surface characteristics. The indication for use statement is substantially equivalent to TiUnite implant, another implant with a modified surface having properties claimed to facilitate bone deposition and healing.

The previously submitted data and additional pre-clinical and clinical data with Fixture MicroThread OsseoSpeed illustrate that the fluoride-modified surface promotes increased and more rapid bone formation compared to the TiOblast surface, as well as increased boneto-implant strength early in the healing phase, which is also maintained over time. This improved early bone support allows safe and efficacious use in all situations and especially in situations with soft bone and whenever immediate installation and immediate and early loading protocols are applied.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - U.S.A." are arranged in a circular pattern around the eagle.

Public Health Service

MAR 2 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Astra Tech, Incorporated C/O Mr. Floyd G. Larson Paxmed International, Limited Liability Company 11234 El Camino Real Suite 200 San Diego, California 92130

Re: K053384

Trade/Device Name: Fixture MicroThread™ OsseoSpeedTM Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: March 14, 2006 Received: March 15, 2006

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 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. Floyd G. 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 (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/dsma/dsmamain.html

Sincerely yours,

Chin S. Liu, Ph.D.

Chiu S. Lin, PhD 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): K053384

Device Name: Fixture MicroThread™ OsseoSpeed™, a component of the Astra Tech Implant System

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Indications for Use:

Fixture MicroThread™ OsseoSpeed™ 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. Fixture MicroThread OsseoSpeed 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 Prescription Use

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

(PI.EASE PONOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Susan furne

and Conner Conney of CDRH, Office of Device Evaluation (ODE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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