ANKYLOS

K012681 · Dentsply Ceramco · DZE · Aug 22, 2003 · Dental

Device Facts

• Record ID: K012681
• Device Name: ANKYLOS
• Applicant: Dentsply Ceramco
• Product Code: DZE · Dental
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

An endosseous dental implant is indicated for surgical placement in the upper or 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 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient must be subject for dental treatment with endosseous implants.

Device Story

Ankylos dental implant system; endosseous root-form device; used for prosthetic attachment to restore chewing function. Implant consists of uncoated pure titanium (grade 2, ISO 5832/II); features threaded rough-surface body and polished cervical margin. Supplied sterile in double glass container with pre-mounted cover screw. Surgical placement performed by dental professionals in clinical setting; supports conventional 2-stage process or single-stage immediate loading (anterior mandible only, 4-implant minimum). Device provides stable foundation for prosthetic appliances; benefits patients by restoring masticatory function.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Material: Uncoated pure titanium (grade 2 per ISO 5832/II). Design: Threaded rough-surface body, polished cervical margin. Form factor: Endosseous root-form implant. Sterilization: Sterile packaging. No software or electronic components.

Indications for Use

Indicated for patients requiring dental restoration via endosseous implants in upper or lower jaw arches. Supports single or multiple unit prosthetic attachments. 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

• Straumann ITI Implant (K984104)
• Branemark System (K992937)

Submission Summary (Full Text)

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K012681

AUG 2 2 2003

510k Summary September 12, 2002

#### Applicant's Name and Address:

Dentsloy Ceramco 6 Terri Lane Burlington, NJ 08016 Fax: [phone] Contact Person: Thomas B. Cameron, Dir. Q. A.

#### Name of Device:

Classification Name: Common / Usual Name: Proprietary Name: Establishment Registration Number: Owner - Operator: Classification;

Implant, Endosseous Dental Implant Ankylos 1225486 2246968 Class III

### Predicate Devices

Straumann ITI Implant (510k - 984104) Branemark System (510k - 992937)

## Description of Device

Ankylos dental implants consist of uncoated pure titanium (grade 2 per ISO 5832/II). The threaded area features a rough structure, the cervical margin is polished. The implants come packaged in a sterile double glass container for contact-free handling. The cover screw has already been mounted in the implant and is only removed prior to placing the abutment.

## Intended Use of the Device

An endosseous dental implant is indicated for surgical placement in the upper or 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 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient must be subject for dental treatment with endosseous implants.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2003

Mr. Thomas B. Cameron Director, Quality Assurance Dentsply Ceramco 6 Terri Lane, Suite 100 Burlington, New Jersey 08016

Re: K012681

Trade/Device Name: Ankylos Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 28, 2003 Received: June 2, 2003

Dear Mr. Cameron:

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. Cameron

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.

Swertfump

Susan Runner, DDS, MA Interim 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:

K012681 510(k) Number (if known):

Device Name: __

Ankylos Implant System

Indications for Use:

An endosseous dental implant is indicated for surgical placement in the upper or 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 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient must be subject for dental treatment with endosseous implants"

(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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Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801, 109)

(Optional Format 1-2-96)

Kain Muley La WSR

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K012681