THE FRIALIT-2® AUROBASE ABUTMENT IS INTENDED FOR USE IN FABRICATION OF MULTIPLE UNIT RESTORATIONS, SINGLE TOOTH ABUTMENTS LABORATORY-AND CUSTOM RESTORATIONS, CONSTRUCTED ANGLED ABUTMENTS IN THE MAXILLA AND MANDIBLE.

Device Description

The FRIALIT-2® AuroBase abutment is a one part abutment with two working areas, a gold cvlinder and a plastic sleeve. The gold cylinder has as the rotational securing device a hexagon, which is the counterpart to the internal hexagon of the FRIALIT-2® implant. The plastic sleeve molded around the gold cylinder and is color-coded in order to differentiate the different diameters. The diameters of the FRIALIT-2® AuroBase abutments correspond to the FRIALIT-2® implant diameters. The following diameters are available: Ø3.8 mm. Ø4.5 mm, Ø5,5 mm and Ø6,5 mm. The FRIALIT-2® AuroBase gold cylinder is manufactured out of a commercial gold alloy. The FRIALIT-2® AuroBase plastic sleeve is manufactured out of a burnable commercial plastic.

AI/ML Overview

This looks like a 510(k) premarket notification for a dental implant abutment, not a medical device that would involve a study with a test set, ground truth, or human readers as described in your request. The document describes a medical device, but it appears to be a physical component (an abutment for dental implants) rather than an AI/software-based medical device that would require the types of studies you've inquired about.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable to the provided 510(k) summary for the FRIALIT-2® AuroBase abutment.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (3i UCLA abutment) through:

Description of Technological Characteristics: Comparing design features like working areas, rotational securing mechanisms (hexagon), and materials.
Material Composition Comparison: A table showing the chemical composition of the gold cylinder for both the proposed device and the predicate device, indicating very similar percentages of Au, Pd, Pt, and Ir.
Preclinical Testing Results: A table comparing static shear strength and dynamic fatigue strength, showing the FRIALIT-2® AuroBase met or exceeded the predicate device's performance.

This type of 510(k) submission typically relies on engineering and material testing to show that the new device is as safe and effective as a legally marketed predicate, rather than clinical trials or AI performance studies.

Summary

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K982576

FRIATEC

510(k) Summary of Safety and Effectiveness VIII.

VIII.1. Submitter Information

Submitter:	FRIATEC AG, Medical Technology Division
Registration Number:	9681851
Address:	Steinzeugstrasse68229 Mannheim / Germany
Contact Person:	Birgit Unger (QA/RA Manager)
Telephone:	011-49-621-486-1549
Fax:	011-49-621-486-1866
e-mail:	birgit.unger@friatec.de
Data Prepared:	July 7th, 1998

VIII.2. Name of Device

Proprietary Name:	FRIALIT-2® AuroBase abutment
Common Name:	Abutment for endosseous implants
Classification Name:	Endosseous Implant

VIII.3. Predicate Device Information

Name:	UCLA abutment
Submitter:	3i Implant Innovations Incorporated
510(k) Number:	K874400

VIII.4. Description of the Device

The diameters of the FRIALIT-2® AuroBase abutments correspond to the FRIALIT-2® implant diameters. The following diameters are available:

Ø3.8 mm. Ø4.5 mm, Ø5,5 mm and Ø6,5 mm.

The FRIALIT-2® AuroBase gold cylinder is manufactured out of a commercial gold alloy. The FRIALIT-2® AuroBase plastic sleeve is manufactured out of a burnable commercial plastic.

VIII.5. Intended Use

The FRIALIT-2® AuroBase is intended for use of the following indications:

fabrication of multiple unit restorations
fabrication of single tooth restorations .
custom abutment fabrication, -
" fabrication of laboratory-constructed angled abutments

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Image /page/1/Picture/1 description: The image shows the logo for FRIATEC. The logo consists of a black triangle with the word "FRIATEC" in bold black letters underneath. The triangle is stylized with a cut-out section on the left side, giving it a unique shape. The logo is simple and modern, using a geometric shape and bold typography to create a recognizable brand identity.

VIII.6. Technological Characteristics

The technological characteristics of the FRIALIT-2® AuroBase abutment are substantially the same as the characteristics of the 3i UCLA abutment. Both devices consist of two working areas. One working area is the gold cylinder. the second working area is the plastic sleeve for the modellation of the later individualized abutment. The material of construction is identical for the FRIALIT-2® AuroBAse and the 3i UCLA abutment. For anti-rotation, both devices use a hexagon that complements th einternal or external hexagon of the implant.

The tables below show technological and preclinical testing results for both the FRIALIT-2® AuroBase and the 3i UCLA abutment.

CompositionGold Cylinder	FRIALIT-2®AuroBase	3i UCLAabutment
Au	57,8	58,0
Pd	21,0	19,5
Pt	19,6	21,1
Ir	1,6	1,7

Table-#VIII.1: Chemical Composition of the gold cylinder FRIALIT-2® AuroBase and 3i UCLA abutment

Preclinical Tests	FRIALIT-2 ® AuroBase	3i UCLA abutment
static shear strenght [lbs]	110,6	81,7
dynamic fatigue strength[lbs]	runour at 40	runout at 40

Table-#VIII.2: Preclinical tests of FRIALIT-2® AuroBase and 3i UCLA abutment

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wings, representing health, services, and people. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 22 1998

FRIATEC AG C/O R. Steve Reitzler, RAC, Vice President, Regulatory Affairs Advanced Bioresearch Associates ABA SAN DIEGO One America Plaza 600 West Broadway, Suite 900 San Diego, California 92101-3302

Re : K982576 FRIALIT-2® AuroBase Model Numbers 45-2446, Trade Name: 45-2456, 45-2466 Regulatory Class: III Product Code: DZE Dated: July 24, 1998 Received: July 24, 1998

Dear Mr. Reitzler:

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 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). 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 aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to

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Page 2 - Mr. Reitzler

comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. accron. In address, In the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Cur Ls/sm
Timothy A. Ulatowski

Timothy A. Ulatgws Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

FRIALIT-2® AuroBase Abutment

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE IN ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Meccer Shupm
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital, Timection 510(k) Number

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.