The XiVE® TG Dental Implant System is indicated for singlestage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular spinted 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 minimu 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 length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

Device Description

The XiVE® TG Dental Implant System consists of transgingival threaded dental implants in 3.4 -4.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® TG Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for splinted crowns, bridges and complete dentures. In the edentulous mandible, the XiVE® TG transgingival dental implants are indicated for immediate loading procedures using the standard protocol.

AI/ML Overview

The provided document is a 510(k) summary for the XiVE® TG Dental Implant System. It presents information regarding substantial equivalence to a predicate device, rather than detailed studies demonstrating performance against pre-defined acceptance criteria for a new device.

Therefore, the requested information, specifically acceptance criteria, device performance from a new study, sample sizes for test sets, ground truth establishment details, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document.

The document primarily focuses on establishing substantial equivalence to a previously cleared device (K024004) due to a change in the surface morphology of the implant.

Here's an explanation of why the requested items are not present:

Table of acceptance criteria and reported device performance: This document asserts substantial equivalence, stating that "Performance evaluations of the XiVE® TG dental implant system show that the device performs as intended." However, it does not provide specific acceptance criteria or quantitative performance data from these evaluations. The focus is on demonstrating that the new device is functionally identical to the predicate.
Sample size for test set and data provenance: No specific test set or study with corresponding sample size and data provenance information is described. The clearance relies on equivalence to a previously cleared device.
Number of experts used to establish ground truth and their qualifications: Not applicable, as there's no diagnostic or interpretative test set described needing expert ground truth.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This device is a dental implant, not an imaging or diagnostic AI tool that would typically involve human readers.
Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a physical medical device (dental implant), not an AI algorithm.
Type of ground truth used: Not applicable, as no ground truth for a diagnostic or interpretative task is required.
Sample size for the training set: Not applicable, as there is no mention of a machine learning or AI model being trained.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does state regarding performance (without specific data):

"Performance evaluations of the XiVE® TG dental implant system show that the device performs as intended." (Section 17.9, "CONCLUSIONS")
The device is "substantially equivalent to the current XiVE® TG Dental Implant Systems in terms of design, materials, mechanical strength, prosthetic and laboratory options and intended use." (Section 17.5, "SUBSTANTIAL EQUIVALENCE")
"The only difference is the change in the surface morphology of the dental implant to the FRIADENT Surface M2.1." (Section 17.7, "TECHNOLOGICAL CHARACTERISTICS")
"The complete surface characterization of the new FRIADENT Surface M2.1 has been detailed in a Device Master File." (Section 17.9, "CONCLUSIONS") This implies that the properties of the new surface were characterized, but the details are not in this summary.

In essence, this 510(k) summary is a declaration of substantial equivalence based on the device's similarity to an already cleared product, with the only change being a surface modification that is presumed not to raise new questions of safety or effectiveness. It does not provide the detailed study results that would typically be found for a novel device or a device making new performance claims.

Summary

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K032284

SECTION 17: 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 17.1

a. Company Name:	FRIADENT GmbH.
b. Company Address:	Steinzeugstrasse 50Mannheim D-68229Germany
c. Company Phone:Company Facsimile:	(011) 49 621 43 02 1121(011) 49 621 43 02 2121
d. Contact Person:	Heike DietzlerRegulatory Affairs Manager
e. Date Summary Prepared:	July 22, 2003

DEVICE IDENTIFICATION 17.2.

a. Trade/Proprietary Name:	XiVE® TG Dental Implant System
b. Classification Name:	Endosseous Dental Implants21 CFR 872.3640

IDENTIFICATION OF PREDICATE DEVICES 173

Company	Device	510(k) No.	Date Cleared
FRIADENT GmbH	XIVE® TransgingivalDental Implant System	K024004	03/03/2003

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DEVICE DESCRIPTION 17.4

SUBSTANTIAL EQUIVALENCE 17.5

The XiVE® TG transgingiyal dental implants with the FRIADENT Surface M2.1 are substantially equivalent to the current XiVE® TG Dental Implant Systems in terms of design, materials, mechanical strength, prosthetic and laboratory options and intended use. The purpose of this submission is to apply the new FRIADENT Surface M2.1 to the endosseous implants.

INTENDED USE 17.6

The XiVE® TG 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 edentuolous mandible, a minimum of four XiVE® TG transgingival 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.

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TECHNOLOGICAL CHARACTERISTICS 17.7

The XiVE® TG transgingival dental implant is available in 3.4, 3.8, and 4.5mm screw-type implants with the FRIADENT Surface M2.1. The lengths of the implants range from 8 - 18mm. The XiVE® TG transgingival dental implants are constructed of CP-2 titanium. A variety of prosthetic options are available for the XiVE® TG system including, AuroBase, PassivFit, Gold Copings, Ball and Socket Attachments, Bar / Clip, and Select Abutments.

The XiVE® TG transgingival dental implants with the FRIADENT Surface M2.1 is equivalent to the current XiVE® TG Dental Implant System in terms of design, materials, mechanical strength, prosthetic options, instructions for use and intended use. The only difference is the change in the surface morphology of the dental implant to the FRIADENT Surface M2.1.

17.8 CLASS III CERTIFICATION AND SUMMARY

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.

CONCLUSIONS 17.9

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 dental implant system show that the device performs as intended. Comparison of the XiVE® TG dental implant system to the predicate devices show that the device is substantially equivalent. The complete surface characterization of the new FRIADENT Surface M2.1 has been detailed in a Device Master File.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design featuring a stylized eagle or bird-like figure with flowing lines, representing the department's mission related to health and human well-being. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2003

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

Re: K032284

Trade/Device Name: XiVE® TG Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: July 22, 2003 Received: July 24, 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Runge

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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K03284

INDICATION FOR USE

510(k) Number:

Device Name:

XiVE® TG Dental Implant System

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Kei Mulvey for MSR
	(Division Sign-Off)

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:	K 032284
Prescription Use	X
	OR
	Over-The-Counter Use

(Per 21 CFR 801.109)CONFIDENTIAL

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.