XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM

K024004 · Friadent GmbH · DZE · Mar 3, 2003 · Dental

Device Facts

• Record ID: K024004
• Device Name: XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM
• Applicant: Friadent GmbH
• Product Code: DZE · Dental
• Decision Date: Mar 3, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XiVE® Transgingival Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four transgingival implants ≥ 9.5mm 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® Transgingival Dental Implant System consists of transgingival threaded dental implants (3.4–5.5mm diameter; 8–18mm length), surgical/laboratory instruments, and prosthetic components. Implants feature FRIOS Deep Profile Surface. System used by dental professionals for single-stage procedures, including single tooth replacement, bridge fixation, and complete dentures. In edentulous mandible, system allows immediate bar-prosthetic loading. Implants provide structural foundation for dental restorations; splinting required for stability. Benefits include reduced surgical stages and immediate loading capability in specific mandibular cases.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and mechanical strength comparisons to predicate devices.

Technological Characteristics

Transgingival threaded dental implants; diameters 3.4-5.5mm; lengths 8-18mm. Features FRIOS Deep Profile Surface coating. Mechanical system includes surgical/laboratory instruments and prosthetic components. No software or electronic components.

Indications for Use

Indicated for patients requiring single-stage dental implant placement for splinted crowns, bridges, or bar-retained overdentures. Applicable for edentulous maxilla (min 4 implants) and edentulous mandible (min 4 implants ≥ 9.5mm between mental foramina).

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

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

Submission Summary (Full Text)

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

MAR 0 3 2003

# SECTION 18:

# SUMMARY OF SAFETY AND EFFECTIVENESS

04

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

### 18.1 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: | February 23, 2003 |

### DEVICE IDENTIFICATION 18.2.

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

#### IDENTIFICATION OF PREDICATE DEVICES 18.3

| Company | Device | 510(k) No. | Date Cleared |
|---------------|--------------------------------|------------|--------------|
| FRIADENT GmbH | FRIALOC® Dental Implant System | K013067 | 04/09/2002 |
| FRIADENT GmbH | XiVE® Dental Implant System | K013867 | 03/15/2002 |

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## DEVICE DESCRIPTION 18.4

The XiVE® Transgingival Dental Implant System consists of transgingival 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® Transgingival Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures and for immediate loading indications in the edentulous mandible.

#### SUBSTANTIAL EQUIVALENCE 18:5

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

#### 18.6 INTENDED USE

The XiVE® Transgingival Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants.

In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together.

In the edentulous mandible, a minimum of four transgingival implants ≥ 9.5mm are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

MAR 0 3 2003

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: K024004

Trade/Device Name: XiVIE® Transgingival Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implants Regulatory Class: III Product Code: DZE Dated: February 6, 2003 Received: February 7, 2003

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 yours.

Susan Runols

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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# INDICATION FOR USE

510(k) Number:

K024004

Device Name:

XiVE® Transgingival Dental Implant System

Indications for Use: The XiVE® Transgingival Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns. bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants.

> In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together.

In the edentulous mandible, a minimum of four transgingival implants ≥ 9.5mm are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Kein Huby for 1952

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

510(k) Number: K024004