FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS

K073075 · Dentsply International, Inc. · DZE · Mar 31, 2008 · Dental

Device Facts

• Record ID: K073075
• Device Name: FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
• Applicant: Dentsply International, Inc.
• Product Code: DZE · Dental
• Decision Date: Mar 31, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FRIADENT Implant systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System) are for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The FRIADENT Implant Systems are 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

FRIADENT Implant Systems consist of root-formed threaded screws manufactured from commercially pure titanium with FRIADENT plus surface coating. Devices are used by dental surgeons in clinical settings for single or two-stage surgical procedures to replace missing teeth. System supports cemented or screw-retained restorations. Immediate placement and function are indicated when good primary stability is achieved in type I or II bone. Multiple tooth applications may be splinted with a bar. Output is a stable dental implant providing a foundation for prosthetic restoration, enabling patient chewing function. Safety and effectiveness are supported by the established marketing history of the unchanged device components.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the established research, development, and marketing history of the unchanged device components.

Technological Characteristics

Root-formed threaded screws; commercially pure titanium; FRIADENT plus surface coating. Mechanical device; no energy source or software. Sterilization method not specified.

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 good primary stability (type I or II bone) is achieved and appropriate occlusal loading is applied to restore chewing function.

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

• Brånemark System Implants (K022562)
• Astra Tech Implants - Dental System (K041492)

Submission Summary (Full Text)

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K073075

## 510(k) SUMMARY

## MAR 3 1 2008

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|---------------------------------------------|
| DATE PREPARED: | October 29, 2007 |
| TRADE OR PROPRIETARY NAME: | FRIADENT Implant Systems/Indication |
| CLASSIFICATION NAME: | Endosseous dental implant (21 CFR 872.3640) |

PREDICATE DEVICES:

Various Brånemark System Implants (K022562) Astra Tech Implants - Dental System (K041492)

DEVICE DESCRIPTION: The FRIADENT Implant Systems consist of root-formed threaded screws made from commercially pure titanium and coated with FRIADENT plus surface.

The indication for use of the FRIADENT Implant Systems includes the immediate loading applications on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone).

INTENDED USE: The FRIADENT Implant systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System) are for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The FRIADENT Implant Systems are 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.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in this submission have been used in legally marketed devices. No changes have been made to these implant systems. This submission expands the indications for use. Therefore, it was determined that no additional biocompatibility testing was necessary.

We believe that the performance data provided and the research and development and marketing history of the unchanged device support the safety and effectiveness of the FRIADENT Implant Systems for the indicated uses.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 3 1 2008

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K073075

Trade/Device Name: FRIADENT Implant Systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 28, 2008 Received: February 29, 2008

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 such additional controls. Existing major regulations affecting vour 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); 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/industry/support/index.html.

Sincerely yours,

Suetia G. Michau Ouis.

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

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K073075

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: FRIADENT Implant Systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System)

Indications for Use:

The FRIADENT Implant systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System) are for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The FRIADENT Implant Systems are 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

MSR

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

510(k) Number: K073075