FRIALIT-2 SELECT COMPONENTS

K993095 · Friadent GmbH · DZE · Dec 9, 1999 · Dental

Device Facts

• Record ID: K993095
• Device Name: FRIALIT-2 SELECT COMPONENTS
• Applicant: Friadent GmbH
• Product Code: DZE · Dental
• Decision Date: Dec 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

The FRIALIT-2 Dental Implant System is intended for single tooth restorations, edentulous spans restored with multiple single teeth, free-standing bridges and to retain overdentures. These implants can be used for immediate, delayed immediate or late implant placement.

Device Story

FRIALIT-2 Select Components (sleeve, try-in implant, try-in abutment) serve as surgical/prosthetic planning accessories for the FRIALIT-2 Dental Implant System. Components are color-coded and match implant body diameters. Used by clinicians in the patient or on laboratory models to assess implant placement, angulation, and soft tissue height prior to final restoration. Output provides physical guidance for surgical planning and abutment selection, aiding in accurate implant positioning and prosthetic fit.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional comparison to the predicate device.

Technological Characteristics

Components include sleeves, try-in implants, and try-in abutments. Design features color-coding for size identification. Materials and design are equivalent to the predicate device. No energy source or software components.

Indications for Use

Indicated for use in the determination of implant placement, implant angle, and measurement of available soft tissue height; also used to determine potential abutment angle and soft tissue height.

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

• 3i Standard Threaded and Self-Tapping Threaded Dental Implant Systems (K950204)

Submission Summary (Full Text)

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DEC - 9 1999

FRIADENT GmbH FRIALIT-2 Select Components Original Premarket 510(k) Notification

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# SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 14:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

#### 14.1 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: | Birgit Unger<br>Quality Management and Regulatory Affairs |
| e. | Date Summary Prepared: | September 10, 1999 |
| DEVICE IDENTIFICATION | | |

#### 14.2. DEVICE IDENTIFICATION

| a. Trade/Proprietary Name: | FRIALIT-2 Select Components<br>Accessories to the FRIALIT-2 Dental<br>Implant Systems |
|----------------------------|---------------------------------------------------------------------------------------|
| b. Classification Name: | Endosseous Dental Implants<br>21 CFR 872.3640 |

#### IDENTIFICATION OF PREDICATE DEVICES 14.3

| Company | Device | 510(k) No. | Date Cleared |
|---------------------|--------------------------|------------|--------------|
| Implant Innovations | 3i Standard Threaded and | K950204 | 09/27/95 |

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#### 14.4 DEVICE DESCRIPTION

The FRIALIT-2 Select Components are part of the FRIALIT-2 Dental Implant System. The components consist if the FRIALIT-2 Select Sleeve, FRIALIT-2 Select Try-in Implant, and FRIALIT-2 Select try-in Abutment. The components come in the same diameters as the implant bodies and are color coded to correspond to size. The components can be used in the patient and/or the laboratory model to help in the determination of implant placement, abutment and implant angle and available soft tissue height.

#### 14.5 SUBSTANTIAL EQUIVALENCE

The FRIALIT-2 Select Components are substantially equivalent to the Implant Innovations, Inc., Pre-angled Surgical and Prosthetic Guide Kits and Tissue Measuring Post Components of the 3 i Standard Threaded/Self-Tapping Threaded Dental Implant Systems.

The fundamental technical characteristics of the FRIALIT-2 Select Components are similar to those of the predicate. The FRIALIT-2 Select Components are equivalent to the Implant Innovations, Inc., components in design, material, and functionality.

#### 1 4.6 INTENDED USE

The FRIALIT-2 Dental Implant System is intended for single tooth restorations, edentulous spans restored with multiple single teeth, free-standing bridges and to retain overdentures. These implants can be used for immediate, delayed immediate or late implant placement.

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## 14.7 TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the FRIALIT-2 Select Components with the predicate device is provided within this submission. Both the FRIALIT-2 Select Components and the predicate device are similar in design, materials and functionality. The FRIALIT-2 Select components are available in diameters corresponding to those of the implant bodies. The components are color-coded for ease of use.

### CLASS III CERTIFICATION AND SUMMARY 14.8

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 14.9

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1999

Friadent GmbH Ms. Carol Patterson Consultant for Friadent GmbH Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, CA 92630

> Re: K993095 Trade Name: Frialit-2 Select Components Requlatory Class: III Product Code: DZE September 10, 1999 Dated: September 16, 1999 Received:

Dear Ms. Patterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Patterson

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timóthy 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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FRIADENT GmbH FRIALIT-2 Select Components Original Premarket 510(k) Notification

# INDICATION FOR USE

| 510(k) Number: | To Be Assigned By FDA |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | FRIALIT-2® Select Components |
| Indications for Use: | The Select Components of the FRIALIT-2® Dental Implant<br>System are indicated for use in the determination of implant<br>placement, implant angle and to measure the available soft<br>tissue height. The Select Components can also be used in<br>determining the potential abutment angle and soft tissue height. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rosser

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 299 510(k) Number _

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

| (Per 21 CFR 801.109) |
|----------------------|
|----------------------|

# CONFIDENTIAL