ASTRA TECH IMPLANT SYSTEM

K101732 · Astra Tech AB · DZE · Feb 23, 2011 · Dental

Device Facts

• Record ID: K101732
• Device Name: ASTRA TECH IMPLANT SYSTEM
• Applicant: Astra Tech AB
• Product Code: DZE · Dental
• Decision Date: Feb 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OsseoSpeed implants are intended to be used: - to replace missing teeth in single or multiple unit applications within the mandible or maxilla - for immediate placement in extraction sites and partially or completely healed alveolar ridge situations - for both one- and two-stage surgical procedures - especially well in soft bone applications where implants with other implant surface treatments may be less effective - together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate - together with immediate loading protocol for single-tooth restorations on implants 8 mm or longer - with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and central incisors.

Device Story

Astra Tech Implant System (OsseoSpeed TX) consists of endosseous root-form dental implants designed to support prosthetic devices for restoring esthetics and chewing function. Implants feature a narrower tapered apex design compared to previous versions, intended for use with a modified drilling protocol in soft bone applications. Implants are placed by dental professionals in clinical settings. The system provides primary mechanical stability in bone, facilitating immediate loading protocols. The device is manufactured from commercially pure titanium. Clinical benefit includes restoration of missing teeth and improved stability in soft bone.

Clinical Evidence

Bench testing only. Comparative analysis performed between OsseoSpeed TX implants using the new soft bone drilling protocol and OsseoSpeed implants using the standard protocol. Calculations of bone-to-implant contact and mechanical stability testing demonstrated that the new design and protocol provide improved primary mechanical stability.

Technological Characteristics

Endosseous root-form dental implants; material: commercially pure titanium (ASTM F67); design: tapered apex; energy source: none (mechanical); connectivity: none; sterilization: standard methods; software: none.

Indications for Use

Indicated for patients requiring replacement of missing teeth in mandible or maxilla; single or multiple unit applications; immediate placement in extraction sites or healed alveolar ridges; one- or two-stage surgical procedures; soft bone applications; immediate loading protocols (excluding single-tooth soft bone type IV).

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 NobelActive Internal Connection Implant (K071370)
• Astra Tech Astra Tech Implant System (K091239)
• Astra Tech Fixture MicroThread™ OsseoSpeed™ (K053384)

Submission Summary (Full Text)

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K101732

510(k) Summary

# Astra Tech Implant System

# 510(k) Summary

FEB 2 3 2011

# Astra Tech AB Astra Tech Implant System

October 28, 2010

# ADMINISTRATIVE INFORMATION

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

Official Contact:

Christina Lewing

Representative/Consultant:

Linda K. Schulz, BSDH, RDH Kevin A. Thomas, PhD PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 [phone] Telephone: Fax: [phone] [e-mail] email: [e-mail]

# DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Product Code: Classification Panel: Reviewing Branch:

Astra Tech Implant System Dental implant Implant, endosseous, root form Class II, 21 CFR 872.3640 DZE Dental Products Panel Dental Devices Branch

#### INTENDED USE

The OsseoSpeed implants are intended to be used:

- to replace missing teeth in single or multiple unit applications within the mandible or . maxilla
- for immediate placement in extraction sites and partially or completely healed alveolar . ridge situations
- for both one- and two-stage surgical procedures .

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- especially well in soft bone applications where implants with other implant surface . treatments may be less effective
- together with immediate loading protocol in all indications, except in single tooth . situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate
- together with immediate loading protocol for single-tooth restorations on implants 8 mm . or longer
- with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and . central incisors.

### DEVICE DESCRIPTION

· Astra Tech Implant System implants are intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The new components of the Astra Tech Implant System included in this submission are OsseoSpeed TX implants which have a narrower tapered apex design compared to OsseoSpeed implants (K053384). They are placed using a modified drilling protocol with new conical drill sizes. The modified drilling protocol is specifically designed for soft bone applications. All other features and procedures of OsseoSpeed TX implants remain the same as those for OsseoSpeed implants.

The purpose of this submission is to add the OsseoSpeed TX implants to the present product line and expand device claims regarding primary stability of Astra Tech Implant System implants.

#### TESTING

Testing was performed to compare OsseoSpeed TX implants using the new soft bone drilling protocol with OsseoSpeed implants using the standard drilling protocol. Calculations also were made to determine bone to implant contact for the two implant/drilling protocol combinations. The design of the OsseoSpeed TX implants, combined with the soft bone drilling protocol. results in improved primary mechanical stability of the implant.

#### EQUIVALENCE TO MARKETED DEVICE

Astra Tech AB in this Premarket Notification demonstrated that, for the purposes of FDA's regulation of medical devices, the Astra Tech Implant System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Nobel Biocare NobelActive Internal Connection Implant cleared under K071370. Astra Tech Astra Tech Implant System cleared under K091239, and Astra Tech Fixture MicroThread™ OsseoSpeed™ cleared under K053384.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of commercially pure titanium conforming to ASTM F67. They encompass the same range of physical dimensions, including diameter and length of the implants. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.

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Astra Tech AB demonstrated that, for the purposes of FDA's regulation of medical devices, the Astra Tech Implant System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices.

The Astra Tech Implant System has the following similarities to the predicate devices:

- has the same intended use, .
- . uses the same operating principle,
- . incorporates the same basic design,
- . incorporates the same materials, and
- has similar packaging and is sterilized using the same materials and processes. .

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

FEB 2 3 2011

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MIJ 20993-0002

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

Re: K101732

Trade/Device Name: Astra Tech Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 28, 2011 Received: January 28, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register. Fir . . . . .

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Page 2- Ms. Schulz

Enclosure

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Kuare

Anthony D. Watson, B.S., M.S., M.B.A. Director

· Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

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# Indications for Use

510(k) Number: K101732

Device Name: Astra Tech Implant System

Indications for Use:

The OsseoSpeed implants are intended to be used:

- to replace missing teeth in single or multiple unit applications within the mandible or . maxilla
- for immediate placement in extraction sites and partially or completely healed alveolar . ridge situations
- for both one- and two-stage surgical procedures o
- especially well in soft bone applications where implants with other implant surface . treatments may be less effective
- together with immediate loading protocol in all indications, except in single tooth ● situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate
- together with immediate loading protocol for single-tooth restorations on implants 8 mm . or longer
- with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and . central incisors.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| 510(k) Number: | K101732 |