FRIALOC DENTAL IMPLANT SYSTEM

K013067 · Friadent GmbH · DZE · Apr 9, 2002 · Dental

Device Facts

• Record ID: K013067
• Device Name: FRIALOC DENTAL IMPLANT SYSTEM
• Applicant: Friadent GmbH
• Product Code: DZE · Dental
• Decision Date: Apr 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FRIALOC Dental Implants are 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 free-standing maxillary and mandibular bridges and barretained overdenture restorations. The bridge must be supported by a minimum of two FRIALOC transgingival threaded implants. In the edentulous maxilla, a minimum of four FRIALOC transgingival threaded implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four FRIALOC transgingival threaded implants are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

Device Story

FRIALOC Dental Implant System consists of transgingival threaded dental implants (3.5mm and 4.0mm diameters; 10-18mm lengths) with FRIOS Deep Profile Surface; includes surgical/laboratory instruments and prosthetic components. Used by dental professionals in clinical settings for tooth replacement. Implants placed in jawbone to support bridges or overdentures; provides stable foundation for prosthetic loading. Edentulous mandible allows immediate bar-prosthetic loading; other applications require 3-4 month healing phase. Benefits include restoration of dental function and aesthetics for edentulous or partially edentulous patients.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and technological comparisons to legally marketed predicate devices (bench testing only).

Technological Characteristics

Transgingival threaded dental implants; 3.5mm and 4.0mm diameters; 10-18mm lengths. Features FRIOS Deep Profile Surface coating. Stepped screw-type design. Materials and coatings are identical to FRIALIT-2 system. Mechanical strength and design equivalent to Branemark Standard system.

Indications for Use

Indicated for patients requiring dental restoration via single-stage implant placement for free-standing maxillary/mandibular bridges or bar-retained overdentures. Requires minimum 3-month healing in good bone or 4-month in spongy bone. Edentulous maxilla requires minimum 4 implants in trapezoidal distribution; edentulous mandible requires minimum 4 implants 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

• Conical Mk II 3.75mm Fixture (K925760)
• Branemark System Implants (K992937)
• FRIALIT-2 Dental Implant With Deep Profile Surface (K945847)

Reference Devices

• Nobel BioCare Branemark Standard Dental Implant System

Submission Summary (Full Text)

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# 013067

FRIADENT GmbH FRIALOC® Dental Implant System Original Premarket 510(k) Notification

#### SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 17:

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:
b. Company Address:

Steinzeugstrasse 50 Mannheim D-68229 Germany

(011) 49 06 21 4 86 1549

(011) 49 06 21 4 86 1866

FRIADENT GmbH.

- Company Phone: C. Company Facsimile:
- Contact Person: రే...

e.

Date Summary Prepared:

Regulatory Affairs Manager

January 30, 2002

Heike Dietzler

#### DEVICE IDENTIFICATION 17.2.

a. Trade/Proprietary Name:

FRIALOC® Dental Implant System

b. Classification Name:

Endosseous Dental Implants 21 CFR 872.3640

#### IDENTIFICATION OF PREDICATE DEVICES 17.3

| Company | Device | 510(k) No. | Date Cleared |
|---------------|-------------------------------------------------------|------------|--------------|
| Nobel BioCare | Conical Mk II<br>3.75mm Fixture | K925760 | 10/05/93 |
| NobelBiocare | Branemark System Implants | K992937 | 02/29/00 |
| FRIADENT GmbH | FRIALIT-2 Dental Implant<br>With Deep Profile Surface | K945847 | 03/15/95 |

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#### 17.4 DEVICE DESCRIPTION

The FRIALOC Dental Implant System consists of transgingival threaded dental implants in 3.5 and 4.0mm diameters with 10 - 18mm lengths. The implants are coated with the FRIOS Deep Profile Surface. The FRIALOC Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for immediate prosthetic loading using bar-retained overdentures in the edentulous mandible. The FRIALOC Dental Implant System can be used for two stage procedures for freestanding posterior maxillary and mandibular bridges.

#### SUBSTANTIAL EQUIVALENCE 17.5

The FRIALOC® dental implant is substantially equivalent to the current FRIALIT-2® Dental Implant Systems in terms of design, materials, coatings and prosthetic options. The FRIALOC® dental implant is substantially equivalent to the Nobel BioCare Conical Mk II dental implant in terms materials, functionality, mechanical strength and intended use.

#### INTENDED USE 17.6

FRIALOC Dental Implants are 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 free-standing maxillary and mandibular bridges and barretained overdenture restorations. The bridge must be supported by a minimum of two FRIALOC transgingival threaded implants. In the edentulous maxilla, a minimum of four FRIALOC transgingival threaded implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four FRIALOC transgingival threaded implants 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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FRIADENT GmbH FRIALOC® Dental Implant System Original Premarket 510(k) Notification

#### TECHNOLOGICAL CHARACTERISTICS 17.7

A comparison of the technological characteristics of the FRIALOC® dental implant with the predicate devices is provided within this submission. The FRIALOC® dental implant is identical to the current FRIALIT-2® dental implants in terms of coatings, materials and prosthetic options. The FRIALOC® dental implant is available in a 3.5 and 4.0 mm stepped screw-type with FRIOS® Deep Profile Surface.

The FRIALOC Dental Implant system is equivalent to the Nobel BioCare Branemark Standard Dental Implant System in terms of design, mechanical strength and intended use.

#### CLASS III CERTIFICATION AND SUMMARY 17.8

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.

#### 510(K) CHECKLIST 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.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 2002

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

Re: K013067

Trade/Device Name: FRIALOC® Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: DZE Dated: January 30, 2002 Received: January 31, 2002

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.

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.

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### Page 2 -- Ms. Patterson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski Director Division of Dental. Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K013067

FRIADENT GmbH FRIALOC® Dental Implant System Original Premarket 510(k) Notification

# INDICATION FOR USE

510(k) Number:

K013067

Device Name:

FRIALOC® Dental Implant System

Indications for Use:

The FRIALOC 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 freestanding maxillary and mandibular bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two FRIALOC transgingival threaded implants.

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

In the edentulous mandible, a minimum of four FRIALOC transgingival threaded implants 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)


| (Division Sign-Off) |
|----------------------------------------|
| Division of Dental, Infection Control, |
| and General Hospital Devices |
| K Number: K013067 |

| Prescription Use | <div> <img alt="Checkmark" src="checkmark.png"/> </div> | OR | Over-The-Counter Use |
|----------------------|---------------------------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

CONFIDENTIAL