XIVE TG ABUTMENTS

K032302 · Friadent GmbH · DZE · Oct 2, 2003 · Dental

Device Facts

• Record ID: K032302
• Device Name: XIVE TG ABUTMENTS
• Applicant: Friadent GmbH
• Product Code: DZE · Dental
• Decision Date: Oct 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

The XiVE® TG Abutment is intended for use to fabricate screw-retained or cementable crowns and bridges.

Device Story

XiVE® TG Abutment is a dental implant accessory used for fabricating screw-retained or cementable crowns and bridges. Constructed of CP-2 titanium, it is available in straight or angled configurations with diameters ranging from 3.4mm to 4.5mm to match XiVE® transgingival implant bodies. The device is used by dental professionals in a clinical setting to support prosthetic restorations. It functions as an interface between the dental implant and the final crown or bridge, facilitating the restoration of patient dentition.

Clinical Evidence

Bench testing only. Performance evaluations confirmed the device performs as intended and is substantially equivalent to predicate devices.

Technological Characteristics

Constructed of CP-2 titanium. Available in straight or angled configurations with diameters 3.4-4.5mm. Designed for compatibility with XiVE® transgingival implant bodies. Mechanical strength and design are consistent with predicate dental abutments.

Indications for Use

Indicated for use in the fabrication of screw-retained or cementable crowns and bridges for patients requiring dental implant restorations.

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® Transgingival Dental Implant System (K024004)
• synOcta Abutment (K022859)

Submission Summary (Full Text)

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# OCT = 2 2003 SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:

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 16.1

| a. Company Name: | FRIADENT GmbH. |
|-----------------------------------------|------------------------------------------------------|
| b. Company Address: | Steinzeugstrasse 50<br>Mannheim D-68229<br>Germany |
| c. Company Phone:<br>Company Facsimile: | (011) 49 06 21 4302 1121<br>(011) 49 06 21 4302 2121 |
| d. Contact Person: | Heike Dietzler<br>Regulatory Affairs Manager |
| e. Date Summary Prepared: | July 23, 2003 |

# 16.2. DEVICE IDENTIFICATION

| a. | Trade/Proprietary Name: | XiVE® TG Abutment<br>Accessory to the XiVE® TG<br>Dental Implant Systems |
|----|-------------------------|--------------------------------------------------------------------------|
| b. | Classification Name: | Endosseous Dental Implants<br>21 CFR 872.3640 |

# 16.3 IDENTIFICATION OF PREDICATE DEVICES

| Company | Device | 510(k) No. | Date Cleared |
|---------------|----------------------------------------------|------------|--------------|
| FRIADENT GmbH | XiVE® Transgingival<br>Dental Implant System | K024004 | 03/03/2003 |
| Staumann USA | synOcta Abutment | K022859 | 09/19/2003 |

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### 16.4 DEVICE DESCRIPTION

The XiVE® TG Abutment is part of the XiVE® TG Transgingival Dental Implant System. The XIVE® TG Abutment is intended for the fabrication of screwretained or cementable crowns and bridges. The XiVE® TG Abutment is constructed of CP-2 titanium and is available in a 3.4 - 4.5mm diameter to correspond to the XiVE® transgingival implant bodies. The XiVE® TG Abutment is available with a straight or angled configuration.

#### ાર્ભર SUBSTANTIAL EQUIVALENCE

The XiVE® TG Abutment is substantially equivalent to the XiVE® TG Bar Coping Abutment. The XiVE® TG Abutment is equivalent to the predicate device in design, functionality, materials, mechanical strength. The XiVE® TG Abutment is substantially equivalent to the synOcta Abutment. The XiVE® TG Abutment is equivalent to the predicate device in functionality, materials and intended use.

#### 16.6 INTENDED USE

The XIVE® TG Abutment is intended for use in the fabrication of screw-retained and cementable crowns and bridges.

# 16.7 TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the XiVE® TG Abutment with the predicate devices is provided within this submission. Both the XiVE® TG Abutment and the predicate device are similar in design, mechanical strength, materials and functionality. The XiVE® TG Abutment is available in diameters corresponding to those of the implant bodies and in a straight or angled configuration.

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# CLASS III CERTIFICATION AND SUMMARY 16.8

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.

# 16.9 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. Performance evaluations of the XiVE® TG abutment show that the device performs as intended. Comparison the XiVE® TG abutment to the predicate devices show that the device is substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2003

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

Re: K032302

Trade/Device Name: XiVE® TG Abutment Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implants Regulatory Class: III Product Code: DZE Dated: July 23, 2003 Received: July 25, 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 (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.

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 vour device to proceed to the market.

If vou 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 Runne

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:

K032302

Device Name:

XiVE® TG Abutment

Indications for Use:

The XiVE® TG Abutment is intended for use to fabricate screw-retained or cementable crowns and bridges.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Huby for MSA

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

510(k) Number: K03230

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use