ANKYLOS C/X DENTAL IMPLANT SYSTEM

K083805 · Dentsply Intl., Inc. · DZE · May 22, 2009 · Dental

Device Facts

• Record ID: K083805
• Device Name: ANKYLOS C/X DENTAL IMPLANT SYSTEM
• Applicant: Dentsply Intl., Inc.
• Product Code: DZE · Dental
• Decision Date: May 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ANKYLOS® C/X Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

Device Story

ANKYLOS® C/X Dental Implant System is a root-formed threaded screw system for dental restoration. It features an integrated indexation within the taper connection, allowing precise abutment positioning and relocation without requiring transfer keys for impression taking. Used by dental professionals in clinical settings for single or multiple tooth replacement; supports cemented or screw-retained restorations. The system restores chewing function through surgical implantation and subsequent prosthetic loading. Benefits include simplified abutment management and clinical efficiency.

Clinical Evidence

Bench testing only. Fatigue testing was performed to compare the subject device against predicate devices, with results showing comparable performance.

Technological Characteristics

Root-formed threaded screws; material: commercially pure titanium; connection: tapered with integrated indexation; components include implants, abutments, gingiva formers, and titanium alloy screws. No software or electronic components.

Indications for Use

Indicated for patients requiring single or multiple tooth replacement via single-stage or two-stage surgical procedures, including immediate placement and function when primary stability is achieved and occlusal loading is appropriate.

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® plus Dental Implant System (K041509)
• Friadent Implant Systems (K073075)

Submission Summary (Full Text)

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K083:805

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DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 1800) 877-0020 Fax [phone] www.dentsply.com

MAY 22 2009

# 510(k) SUMMARY for Title of Submission

- 1. Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
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| Contact Person: | Helen Lewis |
|-------------------|--------------|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |

Date Prepared: December 19, 2008

- 2. Device Name:
- Proprietary Name: . ANK YLOS® C/X Dental Implant System

872.3640

II

- . Classification Name: Endosseous dental implant
- CFR Number: .
- Device Class: .
- . Product Code: DZE
- 3. Predicate Device:

| Company | Device | 510(k) Number | Date Cleared |
|--------------------------------|-------------------------------------|---------------|--------------|
| DENTSPLY<br>International Inc. | ANKYLOS® plus Dental Implant System | K041509 | 08/26/2004 |
| DENTSPLY<br>International | Friadent Implant Systems | K073075 | 03/31/2008 |

- 4. Description of Device:
The new ANK YLOS® C/X Dental Implant System introduces a new configuration of the current ANKYLOS® plus dental implant line. The new
line extension includes the: ANKYLOS® C/X Implant, ANK YLOS C/ Regular Abutments, ANKYLOS /X Regular Abutments, ANKYLOS® Regular C/X Gingiva Former, and the ANK YLOS® Titanium Alloy Screws (Membrane Screw and Fixation Screw).

Premarket Notification

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K083805

The ANKYLOS® C/X Dental Implant was modified to integrate an indexation into the taper connection to provide a precise position of the abutment. With the new index, the relocation of the abutment is possible without using a transfer-kev for the impressions taking.

- న్. Indications for Use:
The ANK YLOS® C/X Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

- 6. Description of Safety and Substantial Equivalence
## Technological Characteristics

All of the components found in ANKYLOS® C/X Implant System have been used in legally marketed devices and were found safe for dental use. The ANKYLOS® C/X Dental Implant System consists of root-formed threaded screws made from commercially pure titanium. The material used for the ANKYLOS® C/X Implant System, as well as the manufacturing methods, are identical to legally marketed devices.

## Non-Clinical Performance Data

The results regarding the fatigue tests of the ANKYLOS® C/X Implant and the predicate devices were comparable. Therefore, it concluded that the ANK YLOS® C/X Implant performs as intended.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis Dentsply International, Incorporated Dentsply Tulsa Dental Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17404

MAY 22 2009

Re: K083805

Trade/Device Name: ANKYLOS® C/X Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 19, 2009 Received: May 20, 2009

Dear Ms. Lewis:

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 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. Lewis

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Susan Runno

Susan Runner, D.D.S., MA Acting 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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K083805

510(k) Number (if known):

Device Name: ANKYLOS® C/X Dental Implant System

Indications for Use:

The ANKYLOS® C/X Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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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)

Kein Muluy for NSR

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

510(k) Number: K083805

Premarket Notification

ANKYLOS® C/X Dental Implant System

DENTSPLY International .

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