FRIADENT PLUS DENTAL IMPLANT SYSTEMS

K040170 · Friadent GmbH · DZE · Oct 27, 2004 · Dental

Device Facts

• Record ID: K040170
• Device Name: FRIADENT PLUS DENTAL IMPLANT SYSTEMS
• Applicant: Friadent GmbH
• Product Code: DZE · Dental
• Decision Date: Oct 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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® 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. 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.

Device Story

Endosseous dental implants (FRIALIT, XiVE, XiVE TG) featuring 'PLUS' surface treatment; intended for surgical placement into jawbone by dental professionals; provides foundation for prosthetic restorations (crowns, bridges, overdentures). PLUS surface (grit-blasted, high-temperature acid-etched) designed to enhance osseointegration and removal torque compared to previous surface iterations. Used in clinical dental settings; supports immediate, delayed, or late loading protocols depending on implant type and bone quality. Benefits include improved implant stability and integration strength, facilitating functional and aesthetic tooth replacement.

Clinical Evidence

No human clinical trials presented. Evidence consists of preclinical physiochemical surface characterization and animal studies conducted at the University of Tubingen, University of Cologne, and University of São Paulo. Animal models (pigs) evaluated loaded/unloaded implants, immediate placement in infected sites, and laser therapy effects. Results indicate higher removal torque values for PLUS surface implants compared to solely acid-etched or anodic oxidized surfaces, supporting enhanced integration stability.

Technological Characteristics

Endosseous dental implants with grit-blasted and high-temperature acid-etched 'PLUS' surface. Materials and mechanical design are consistent with predicate systems. Intended for surgical implantation into maxillary or mandibular bone. No electronic components, software, or energy sources involved.

Indications for Use

Indicated for patients requiring dental restorations including single tooth, bridge, and overdenture support. Specific populations include edentulous mandible/maxilla patients requiring splinted implants. Contraindicated for sites not meeting specific bone quality or length requirements (e.g., <9.5mm or <11mm depending on specific system/region).

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

• FRIALIT® Dental Implant System (K031671)
• XiVE® S Dental Implant System (K032158)
• XiVE® TG Dental Implant System (K032284)
• XiVE® D 3.0 Dental Implant System (K032302)

Submission Summary (Full Text)

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

70

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 50<br>Mannheim D-68229<br>Germany |
| c. | Company Phone:<br>Company Facsimile: | (011) 49 06 21 4 86 1549<br>(011) 49 06 21 4 86 1866 |
| d. | Contact Person: | Heike Dietzler<br>Regulatory Affairs Manager |
| e. | Date Summary Prepared: | September 28, 2004 |

#### DEVICE IDENTIFICATION 16.2.

| a. Trade/Proprietary Name: | FRIALIT® PLUS Dental Implant System<br>XiVE® S PLUS Dental Implant System<br>XiVE® TG PLUS Dental Implant System<br>XiVE® D 3.0 PLUS Dental Implant System |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b. Classification Name: | Endosseous Dental Implants<br>21 CFR 872.3640 |

### IDENTIFICATION OF PREDICATE DEVICES 16.3

| Company | Device | 510(k) No. | Date Cleared |
|---------------|--------------------------------------|------------|--------------|
| FRIADENT GmbH | FRIALIT® Dental Implant<br>System | K031671 | 08/14/2003 |
| | XiVE® S Dental Implant<br>System | K032158 | 08/14/2003 |
| | XiVE® TG Dental Implant<br>System | K032284 | 08/14/2003 |
| | XiVE® D 3.0 Dental Implant<br>System | K032302 | 10/02/2003 |

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#### DEVICE DESCRIPTION 16.4

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.

#### 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 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

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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 [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,

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 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® 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.

OR

(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) | <img alt="Signature" src="signature.png"/> |
|--------------------------------------------------------|------------------------------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital,<br>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)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)