ANKYLOS DENTAL IMPLANT SYSTEM

K041509 · Friadent GmbH · DZE · Aug 26, 2004 · Dental

Device Facts

• Record ID: K041509
• Device Name: ANKYLOS DENTAL IMPLANT SYSTEM
• Applicant: Friadent GmbH
• Product Code: DZE · Dental
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

Device Story

ANKYLOS Dental Implant System comprises threaded CP-2 titanium implants (3.5-7.0 mm diameter, 8-17 mm length), surgical instruments, and prosthetic components. Designed for single/multiple unit prosthetics via conventional 2-stage or single-stage surgical procedures. Features FRIADENT surface modification. Used by dental clinicians in clinical settings to restore chewing function. Implants provide root-form foundation for prosthetic attachments. Immediate loading protocol limited to anterior mandible using 4 interforaminal implants. System includes various prosthetic options (Standard, Permador, Balance, SynCone). Benefits include restoration of dental function and aesthetics.

Clinical Evidence

Bench testing only. Performance evaluations demonstrated the device performs as intended. No clinical data provided.

Technological Characteristics

Screw-type endosseous dental implants; material: CP-2 titanium; diameters: 3.5, 4.5, 5.5, 7.0 mm; lengths: 8-17 mm; surface: FRIADENT surface; prosthetic options: Standard, Permador, Balance, SynCone systems.

Indications for Use

Indicated for patients requiring dental treatment with endosseous implants for single or multiple unit prosthetic attachment in upper/lower jaw arches. Immediate loading restricted to anterior mandible using 4 interforaminal implants; not for single, unsplinted implants.

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

• ANKYLOS Dental Implant System (K012087)
• XiVE Dental Implant System (K032158)
• XiVE Dental Implant System (K021318)

Submission Summary (Full Text)

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## AUG 2 6 2004

#### SECTION 17: SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

#### 17.1 SUBMITTER INFORMATION

| a. Company Name: | FRIADENT GmbH. |
|-----------------------------------------|----------------------------------------------------|
| b. Company Address: | Steinzeugstrasse 50<br>Mannheim D-68229<br>Germany |
| c. Company Phone:<br>Company Facsimile: | (011) 49 621 43 02 1121<br>(011) 49 621 43 02 2121 |
| d. Contact Person: | Heike Dietzler<br>Regulatory Affairs Manager |
| e. Date Summary Prepared: | May 24, 2004 |

### 17.2. DEVICE IDENTIFICATION

| a. Trade/Proprietary Name: | ANKYLOS® Dental Implant System |
|----------------------------|-----------------------------------------------|
| b. Classification Name: | Endosseous Dental Implants<br>21 CFR 872.3640 |

### 17.3 IDENTIFICATION OF PREDICATE DEVICES

| Company | Device | 510(k) No. | Date Cleared |
|---------------|-----------------------------------|------------|--------------|
| FRIADENT GmbH | ANKYLOS®<br>Dental Implant System | K012087 | 08/22/2003 |
| FRIADENT GmbH | XiVE®<br>Dental Implant System | K032158 | 08/14/2003 |
| FRIADENT GmbH | XiVE®<br>Dental Implant System | K021318 | 07/02/2002 |

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#### 17.4 DEVICE DESCRIPTION

The ANK YLOS® Dental Implant System consists of threaded dental implants in 3.5 - 7.0 mm diameters with 8 - 17 mm lengths. The implants are coated with the FRIADENT Surface. The ANKYLOS® Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. In the edentulous mandible, the ANK YLOS® dental implants are indicated for immediate loading procedures using the standard protocol.

#### 17.5 SUBSTANTIAL EQUIVALENCE

The ANK YLOS® dental implants with the FRIADENT Surface are substantially equivalent to the current ANK YLOS® Dental Implant System in terms of design, materials, mechanical strength, prosthetic and laboratory options and intended use. The purpose of this submission is to apply the FRIADENT Surface to the endosseous implants.

#### 17.6 INTENDED USE

An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

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#### TECHNOLOGICAL CHARACTERISTICS 17.7

The ANK YLOS® dental implant is available in 3.5, 4.5, 5.5 and 7.0 mm screw-type implants with the FRIADENT Surface. The lengths of the implants range from 8 - 17 mm. The ANK YLOS® dental implants are constructed of CP-2 titanium. A variety of prosthetic options are available for the ANK YLOS® system including, Standard System, Permador System, Balance System, and SynCone® System.

The ANK YLOS® dental implants with the FRIADENT Surface is equivalent to the current ANKYLOS® Dental Implant System in terms of design, materials, prosthetic options, instructions for use and intended use. The only difference is the change in the surface morphology of the dental implant to the FRIADENT Surface.

#### 17.8 CLASS III CERTIFICATION AND SUMMARY

This notification contains a Class III certification and summary of adverse safety and effectiveness information pursuant to 513(f) of the Federal Food, Drug, and Cosmetic Act.

#### 17.9 CONCLUSIONS

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission. Performance evaluations of the ANK YLOS® dental implant system show that the device performs as intended. Comparison of the ANK YLOS® dental implant system to the predicate devices shows that the device is substantially equivalent. The complete surface characterization of the FRIADENT Surface has been detailed in a Device Master File.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2004

FRIADENT GmbH C/O Ms. Carol Patterson Patterson Consulting Group, Incorporated 21911 Erie Lane Lake Forest, California 92630

Re: K041509

Trade/Device Name: ANKYLOS® Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: August 13, 2004 Received: August 17, 2004

Dear Ms. Patterson:

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. Patterson

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 vours.

Chiu Lin, 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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# INDICATION FOR USE

510(k) Number:

ANKYLOS® Dental Implant System Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|----------------------|------------------------------------------------------------------------------------|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |
| | (Division Sign-Off) | | | |
| | Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | | | |
| 510(k) Number: | K041509 | | | |

CONFIDENTIAL