XIVE DENTAL IMPLANT SYSTEM

K021318 · Friadent GmbH · DZE · Jul 2, 2002 · Dental

Device Facts

• Record ID: K021318
• Device Name: XIVE DENTAL IMPLANT SYSTEM
• Applicant: Friadent GmbH
• Product Code: DZE · Dental
• Decision Date: Jul 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XiVE® Dental Implant System is indicated as follows: once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XIVE dental implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.

Device Story

XiVE Dental Implant System comprises subgingival threaded dental implants, surgical/laboratory instruments, and prosthetic components. Implants (3.4-5.5mm diameter; 8-18mm length) feature FRIOS Deep Profile Surface; constructed of CP-2 titanium. Used by dental professionals for two-stage procedures; supports single tooth, bridge, and overdenture restorations. Enables immediate loading in anterior mandible using four splinted implants. System provides mechanical fixation for dental prosthetics; benefits patients through restoration of oral function and aesthetics. Evaluation includes compressive/static strength testing and finite element analysis.

Clinical Evidence

Bench testing only. Evidence includes compressive and static strength testing and finite element analysis.

Technological Characteristics

Screw-type endosseous dental implants; diameters 3.4-5.5mm; lengths 8-18mm. Material: CP-2 titanium. Surface: FRIOS® Deep Profile Surface. Includes various prosthetic abutments (e.g., EstheticBase, Cerabase, AuroBase, Protect, Ball and Socket, Telescopic). Mechanical testing performed via compressive/static strength and finite element analysis.

Indications for Use

Indicated for patients requiring single tooth, bridge, or overdenture restorations following osseointegration. In edentulous mandibles, indicated for immediate bar-prosthetic loading using at least four implants (≥9.5mm) placed between mental foramina and rigidly splinted.

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

• XiVE® Dental Implant System (K013867)
• FRIALOC® Dental Implant System (K013067)

Submission Summary (Full Text)

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K021318

FRIADENT GmbH XiVE® Dental Implant System Original Premarket 510(k) Notification

#### SECTION 15: 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.

#### SUBMITTER INFORMATION 15.1

| 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: | April 24, 2002 |

#### DEVICE IDENTIFICATION 15.2.

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

#### IDENTIFICATION OF PREDICATE DEVICES 15.3

| Company | Device | 510(k) No. | Date Cleared |
|---------------|-----------------------------------|------------|--------------|
| FRIADENT GmbH | XiVE® Dental Implant<br>System | K013867 | 03/15/02 |
| FRIADENT GmbH | FRIALOC® Dental Implant<br>System | K013067 | 04/09/02 |

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#### DEVICE DESCRIPTION 15.4

The XiVE Dental Implant System consists of subgingival threaded dental implants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIOS Deep Profile Surface. The XiVE Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for two stage procedures for single tooth replacement, fixation of bridges and complete dentures and for immediate loading procedures using four implants in the anterior mandible.

#### 15.5 SUBSTANTIAL EQUIVALENCE

The XiVE® dental implant is identical to the current XiVE® Dental Implant System in terms of design, materials, coatings, prosthetic options and mechanical attributes. The XiVE® dental implant is substantially equivalent to the FRIADENT FRIALOC® Dental Implant System in terms of intended use.

#### INTENDED USE 15.6

The XiVE® Dental Implant System is indicated as follows: once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XIVE dental implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.

#### 15.7 TECHNOLOGICAL CHARACTERISTICS

The XIVE® Dental Implant System with the expanded indications is identical to the current XiVE® Dental Implant System. The XiVE® dental implant is available in 3.4, 3.8, 4.5 and 5.5 mm screw-type implants with FRIOS® Deep Profile Surface. The lengths of the implants range from 8 - 18mm. The XiVE dental implants are constructed of CP-2 titanium. A variety of prosthetic options are available for the XiVE system including, MH-6, MH-2, EshteticBase, Cerabase, AuroBase and Protect Abutments, PassivFit, Ball and Socket

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Attachments, Bar Copings, Round Bar, Bar Clip, and Telescopic Abutments. The XiVE dental implant system was tested for compressive and static strength and finite element analysis.

#### CLASS III CERTIFICATION AND SUMMARY 15.8

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.

#### 15.9 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. Design evaluations of the XIVE Dental Implant System show that the device is substantially equivalent to the FRIALOC Dental Implant. Comparison the XiVE Dental Implant System to the predicate devices show that the device is substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a person with outstretched arms. The logo is black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K021318

Trade/Device Name: XiVE® Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: DZE Dated: April 24, 2002 Received: April 25, 2002

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.

1 - 2 201

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.

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.

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## Page 2 - Ms. Patterson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Timothy A. Ulatowski 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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K021318

# INDICATION FOR USE

510(k) Number:

| Device Name: | XiVE® Dental Implant System |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The XiVE Dental Implant System is indicated for the<br>following: |
| | Once the implant has osseointegrated, it serves to support<br>single tooth, bridge and overdenture restorations. |
| | In the edentulous mandible, a minimum of four XiVE<br>dental implants (≥ 9.5mm length) are placed between the<br>mental foramina and rigidly splinted together. In this case,<br>bar-prosthetic loading is possible immediately after implant<br>placement. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ranser

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number .

Prescription Use _ ﺴﻴﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

CONFIDENTIAL