FRIALIT-2 ESTHETICBASE ABUTMENT

K013438 · Friadent GmbH · DZE · Dec 20, 2001 · Dental

Device Facts

• Record ID: K013438
• Device Name: FRIALIT-2 ESTHETICBASE ABUTMENT
• Applicant: Friadent GmbH
• Product Code: DZE · Dental
• Decision Date: Dec 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

The FRIALIT-2® EstheticBase Abutment is intended for use to fabricate screw-retained or cementable crowns and bridges.

Device Story

FRIALIT-2® EstheticBase Abutment is a dental implant component used to fabricate screw-retained or cementable crowns and bridges. Constructed of CP-2 titanium; available in various diameters matching FRIALIT-2® implant bodies; features gingival cuff heights of 1, 2, 3, or 5mm; available in straight or angled configurations. Used by dental professionals in clinical settings to restore missing teeth. The abutment connects the endosseous implant to the prosthetic crown or bridge, providing structural support for the dental restoration.

Clinical Evidence

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

Technological Characteristics

Constructed of CP-2 titanium. Available in multiple diameters corresponding to FRIALIT-2® implant bodies, with gingival cuff heights of 1, 2, 3, or 5mm. Configurations include straight and angled. Mechanical dental implant component.

Indications for Use

Indicated for patients requiring dental restoration via screw-retained or cementable crowns and bridges supported by the FRIALIT-2® Dental Implant System.

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

• Nobel BioCare TiAdapt Abutment System (K971706)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

MAR 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K013438

Trade/Device Name: Frialit-2 Estheticbase Abutment Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: NHA Dated: October 15,2001 Received: October 17,2001

Dear Ms. Patterson:

This letter corrects our substantially equivalent letter of December 20,2001 regarding the company name.

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 (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 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 (OS) 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 continue 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.

Sujāsh Michau Oms

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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113438

# INDICATION FOR USE

To Be Assigned By FDA 510(k) Number:

FRIALIT-2® EstheticBase Abutment Device Name:

The FRIALIT-2® EstheticBase Abutment is intended for use Indications for Use: to fabricate screw-retained or cementable crowns and bridges.

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

Concurrence of CDRH , Office of Device Evaluation (ODE)

A. Blackwell for M.S. Runner

(Division Sign-Off) Division & Dental, Infection Control, and General Hospital Devi F 10/k) Number

Prescription Use

OR

Over-The-Counter Use

(Per21 CFR 801.109)

CONFIDENTIAL

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DEC 2 0 2001

# SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:

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 16.1

16.2.

| 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: | October 15, 2001 |
| DEVICE IDENTIFICATION | |
| a. Trade/Proprietary Name: | FRIALIT-2® EstheticBae Abutment |

Accessories to the FRIALIT-2® Dental Implant Systems

b. Classification Name: Endosseous Dental Implants 21 CFR 872.3640

#### IDENTIFICATION OF PREDICATE DEVICES 163

| Company | Device | 510(k) No. | Date Cleared |
|---------------|-------------------------|------------|--------------|
| Nobel BioCare | TiAdapt Abutment System | K971706 | 07/21/1997 |

108

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#### 16.4 DEVICE DESCRIPTION

The FRIALIT-2® EstheticBase Abutment is part of the FRIALIT-2® Dental Implant System. The EstheticBase Abutment is intended for the fabrication of screw-retained or cementable crowns and bridges. The EstheticBase Abutment is constructed of CP-2 titanium and is available in the same diameters as the FRIALIT-2® implant bodies. Each EstheticBase Abutment diameter is available with a 1, 2, 3, or 5mm gingival cuff height. The EstheticBase Abutment is available with a straight or angled configuration.

#### 16.5 SUBSTANTIAL EQUIVALENCE

The FRIALIT-2® EstheticBase Abutment is substantially equivalent to the Nobel BioCare TiAdapt Abutment System.

The fundamental technical characteristics of the FRIALIT-2® EstheticBase Abutment and components are similar to those of the predicate. The FRIALIT-2 9 EstheticBase Abutment is equivalent to the Nobel BioCare TiAdapt Abutment in design, functionality, materials and intended use.

#### 16.6 INTENDED USE

The FRIALIT-2® EstheticBase Abutment is intended for use in the fabrication of screw-retained and cementable crowns and bridges.

## TECHNOLOGICAL CHARACTERISTICS 16.7

A comparison of the technological characteristics of the FRIALIT-2® EstheticBase Abutment with the predicate devices is provided within this submission. Both the FRIALIT-2® EstheticBase Abutment and the predicate devices are similar in design, materials and functionality. The FRIALIT-20 EstheticBase Abutment is available in diameters corresponding to those of the

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implant bodies. Each EstheticBase Abutment diameter is available with a 1, 2, 3, or 5mm gingival cuff height and in a straight or angled configuration.

# CLASS III CERTIFICATION AND SUMMARY 16.8

This notification contains a Class III certification and summery of adverse safety and effectiveness information pursuant to 513(f) of the Federal Food, Drug, and Cosmetic Act.

## 16.9 510(K) CHECKLIST

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Nitification 510(k) Reviewer's Checklist is provided in this submission.