The FRIALIT® PLUS Dental Implant System is indicated for use in single tooth restorations, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.

The XiVE®S PLUS Dental Implant System is indicated for the following: 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.

The XiVE® D3.0 PLUS Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.

The XiVE® TG PLUS 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 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 FRIALIT®, XiVE® and XiVE® TG dental implants with the new FRIADENT Surface have been cleared for commercial distribution. The purpose of this application is to change the name of the surface to PLUS and obtain clearance for additional marketing claims associated with the PLUS surface.

AI/ML Overview

This 510(k) summary describes a modification to an existing dental implant system, specifically changing the surface name to "PLUS" and seeking clearance for associated marketing claims. As such, the submission focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing de novo performance criteria against acceptance thresholds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (As Implied by Substantial Equivalence and Preclinical/Animal Studies)	Reported Device Performance
Biocompatibility/Surface Characteristics	The "PLUS" surface should exhibit favorable physiochemical surface characteristics and support osseointegration comparable to or better than existing FRIADENT surfaces and other commercially available surfaces.	Preclinical evaluations at the University of Tubingen, Germany, compared physiochemical surface characteristics to other commercially available surfaces. Animal studies (University of Cologne, Germany; University of São Paulo, Brazil) evaluated loaded and unloaded implants, immediate placement in infected sites, and the effect of laser therapy on osseointegration. Conclusion: "Results of these studies support the PLUS surface characteristics, name and advertising claims for the FRIADENT Dental Implant Systems." Specific mention of "higher removal torque values compared to solely acid-etched implants and anodic oxidized textured implants" after 5 months, interpreted as "an increase in the strength of endosseous implant integration and implant stability."
Mechanical Strength	Maintain mechanical strength comparable to existing FRIADENT dental implant systems.	Stated that the new systems are "substantially equivalent to the current FRIADENT® Dental Implant Systems in terms of... mechanical strength."
Intended Use	The modified devices should remain suitable for their indicated uses (single tooth restorations, bridges, overdentures, various implant placement timelines).	The intended uses for the FRIALIT® PLUS, XiVE® S PLUS, XiVE® D3.0 PLUS, and XiVE® TG PLUS systems are clearly outlined and align with general dental implant applications.
Safety and Effectiveness	The device should be safe and effective for its intended use, demonstrating substantial equivalence to predicate devices.	The submission provides a "Class III certification and summary of adverse safety and effectiveness information pursuant to 513(f) of the Federal Food, Drug, and Cosmetic Act." The overall conclusion is that "Comparison of the FRIADENT dental implant systems to the predicate device shows that the device is substantially equivalent."

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of implants or subjects. The studies were preclinical and animal studies.
Data Provenance:
- Country of Origin: Germany (University of Tubingen, University of Cologne) and Brazil (University of São Paulo).
- Retrospective or Prospective: Not explicitly stated, but preclinical and animal studies are typically prospective in their design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable in the context of this 510(k) summary. The "ground truth" for these types of studies is derived from objective measurements (physiochemical analysis, biomechanical testing, histological evaluation in animal models) performed by researchers at the respective universities, not through expert consensus on interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical imaging). The studies involved laboratory and animal experiments with quantifiable outcomes.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This submission is for a dental implant system (hardware), not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" was established through:

Physiochemical surface analyses: Laboratory measurements of surface properties.
Histological and biomechanical analyses in animal models: Evaluation of osseointegration, bone-implant contact, and removal torque values in vivo. This is akin to "pathology" or objective biological outcomes in an animal setting.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set. The studies described are traditional preclinical and animal investigations.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is not an AI/ML device.

Summary

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FRIADENT® PLUS Dental Implant Systems Original Premarket 510(k) Notification

OCT 27 2004

SECTION 16: 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.

16.1 SUBMITTER INFORMATION

a.	Company Name:	FRIADENT GmbH.
b.	Company Address:	Steinzeugstrasse 50Mannheim D-68229Germany
c.	Company Phone:Company Facsimile:	(011) 49 06 21 4 86 1549(011) 49 06 21 4 86 1866
d.	Contact Person:	Heike DietzlerRegulatory Affairs Manager
e.	Date Summary Prepared:	September 28, 2004

DEVICE IDENTIFICATION 16.2.

a. Trade/Proprietary Name:	FRIALIT® PLUS Dental Implant SystemXiVE® S PLUS Dental Implant SystemXiVE® TG PLUS Dental Implant SystemXiVE® D 3.0 PLUS Dental Implant System
b. Classification Name:	Endosseous Dental Implants21 CFR 872.3640

IDENTIFICATION OF PREDICATE DEVICES 16.3

Company	Device	510(k) No.	Date Cleared
FRIADENT GmbH	FRIALIT® Dental ImplantSystem	K031671	08/14/2003
	XiVE® S Dental ImplantSystem	K032158	08/14/2003
	XiVE® TG Dental ImplantSystem	K032284	08/14/2003
	XiVE® D 3.0 Dental ImplantSystem	K032302	10/02/2003

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DEVICE DESCRIPTION 16.4

16.5 SUBSTANTIAL EQUIVALENCE

The FRIADENT® PLUS Dental Implant Systems are substantially equivalent to the current FRIADENT® Dental Implant Systems in terms of design, materials, coatings, mechanical strength, prosthetic options and single tooth intended use.

16.6 INTENDED USE

The XiVE® D3.0 PLUS Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.

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KC40170

FRIADENT® PLUS Dental Implant Systems Original Premarket 510(k) Notification

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.

16.7 TECHNOLOGICAL CHARACTERISTICS

Preclinical evaluations of the FRIADENT PLUS Surface were conducted at the University of Tubingen, Germany. Several studies were conducted to determine the physiochemical surface characteristics in comparison to other commercially available surfaces.

Animal studies of the FRIADENT PLUS Surface were conducted at the University of Cologne, Germany, and the University of São Paulo, Brazil. Studies involved the evaluation of loaded and unloaded implants in pigs, immediate implant placement in periodontally infected sites, and the effect of visible and NIR low intensity laser therapy on implant osseointegration. Results of these studies support the PLUS surface characteristics, name and advertising claims for the FRIADENT Dental Implant Systems.

16.8 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.

16.9 CONCLUSIONS

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewers Checklist is provided in this submission. Preclincal evaluations and animal studies of the FRIADENT PLUS surface have been presented to substantiate the name PLUS and associated marketing claims. Comparison of the FRIADENT dental implant systems to the predicate device shows that the device is substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 2004

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

Re: K040170

Trade/Device Name: FRIADENT PLUS Dental Implant Systems Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: July 28, 2004 Received: August 11, 2004

Dear Ms. White:

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. White

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 (240) 276-0115. 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 yours,

CluLs
Chin Lin, Ph.D.

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

Enclosure

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FRIADENT PLUS Dental Implant Systems Original Premarket 510(k) Notification

INDICATION FOR USE

510(k) Number: K040170

Device Name:

FRIADENT PLUS Dental Implant Systems

Indications for Use:

The XiVE® PLUS Dental Implant System is indicated for the following: 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 (≥11mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The XiVE® D3.0 PLUS Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 and 10 and 23 to 26.

(continue next page)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109).

Over-The-Counter Use _______________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of Anesthesiology, General Hospital,Infection Control, Dental Devices
510(k) Number	K040170

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INDICATION FOR USE (Continued)

510(k) Number:

K040170

Device Name: PLUS Dental Implant Systems

Indications for Use: (continued)

The XiVE® TG PLUS 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 barretained 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 (≥11mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

FRIADENT PLUS grit-blasted and high temperature acid-etched implants display higher removal torque values compared to solely acid-etched implants and anodic oxidized textured implants. The high removal torque values of FRIADENT PLUS implants after a loading period of 5 months may be interpreted as an increase in the strength of endosseous implant integration and implant stability.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.