AVANA Dental Implant Systems are designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium fixture when surgically implanted under controlled conditions, as per well known clinical studies. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Device Description

The Avana SS-II Implant is a threaded, root form endosseous implant comprised of an internal octa, one-stage 8° morse tapered device manufactured from commercially pure titanium. The implant's external threaded surfaces are roughened to facilitate tissue and bone integration. The implant's self-tapping feature may be used with or without pre-tapping the bone. System components for restorative purposes include: screw-on and cemented abutments, healing abutments, and angled abutments. Surgical accessories include drills, depth gages, drivers, torque wrenches, taps, reamers and fixture mount removal tool.

AI/ML Overview

This document describes the acceptance criteria and study proving the device meets those criteria for the AVANA Dental Implant System.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Biocompatibility	Verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices.	Biocompatibility of the AVANA Dental Implant System was verified in accordance with ISO 10993-1.
Surface Treatment Performance	Animal studies conducted to determine the performance of the surface treatment.	Animal studies were conducted to determine the performance of the surface treatment.
Device Durability	In-vitro performance tests conducted to establish device durability (e.g., compression and fatigue tests).	In-vitro performance tests were conducted to establish device durability, including compression and fatigue tests.
Material Characterization	In-vitro performance tests conducted to characterize the implant surface treatment and purity (e.g., spectroscopic studies).	In-vitro performance tests were conducted to characterize the implant surface treatment and purity, including spectroscopic studies.
Substantial Equivalence	Device is substantially equivalent to predicate devices in construction, intended use, and principles of operation.	The AVANA Dental Implant System is substantially equivalent to the predicate devices in its construction, intended use, and principles of operation.

2. Sample Size and Data Provenance

The provided text does not specify the exact sample sizes used for the biocompatibility animal studies or the in-vitro performance tests. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

The provided information does not indicate the number of experts used to establish ground truth for any specific test set, nor does it state their qualifications. The studies mentioned (biocompatibility, animal studies, in-vitro performance) are laboratory or animal model-based, not involving human expert interpretation of data in the way a clinical diagnostic device might.

4. Adjudication Method

The provided information does not describe any adjudication method as it pertains to human interpretation of data. The types of studies cited (biocompatibility, animal, in-vitro) do not typically involve human adjudication in the context of establishing ground truth for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This device is an endosseous implant, a physical medical device, not a diagnostic imaging or AI-assisted system that typically undergoes MRMC studies to evaluate human reader improvement.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study (i.e., algorithm only without human-in-the-loop performance) was done. This is not an algorithmic or AI device.

7. Type of Ground Truth Used

The ground truth for this device is based on:

Established standards and methodologies: For biocompatibility, it's ISO 10993-1.
Biological responses: For surface treatment performance, it's likely based on physiological reactions in animal models.
Engineering and material science measurements: For device durability and material characterization, it's based on objective physical measurements from laboratory tests (e.g., compression, fatigue, spectroscopy).

8. Sample Size for Training Set

This device is a physical medical implant, not a machine learning model, therefore, there is no concept of a "training set" as understood in the context of AI or algorithms.

9. How Ground Truth for Training Set Was Established

As there is no training set for this type of device, this question is not applicable.

Summary

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K051576

SEP - 1 2005

510(k) Summary

Prepared May 24, 2005

TRADE NAME	AVANA Dental Implant System
GENERIC NAME	Endosseous Implant
CLASSIFICATION	Class II (21 CFR 872.3640)
SUBMITTED BY	EK SCIENCE REASEARCH INTL. CO.9494 Silver Fern Pl.Rancho Cucamonga, CA 91730tel. (909) 980-9933fax. (909) 980-9951email - ekscience@usa.comforOsstem Co., Ltd.#38-44, Guje 3-DongBusanRepublic of Korea612-073
CONTACT	Mr. Ki Won Kim
PREDICATEDEVICE	Lifecore Stage -1 Single Stage RBM Dental Implant System, K-003226Osstem Co. 3A Dental Implant System, K011879Swissplus Dental Implant, K-002188
DEVICEDESCRIPTION	The Avana SS-II Implant is a threaded, root form endosseousimplant comprised of an internal octa, one-stage 8° morse tapereddevice manufactured from commercially pure titanium. Theimplant's external threaded surfaces are roughened to facilitatetissue and bone integration. The implant's self-tapping feature maybe used with or without pre-tapping the bone. System componentsfor restorative purposes include: screw-on and cementedabutments, healing abutments, and angled abutments. Surgicalaccessories include drills, depth gages, drivers, torque wrenches,taps, reamers and fixture mount removal tool.

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osstem co., LTD. TRADITIONAL 510(K): AVANA DENTAL IMPLANT SYSTEM

K05/576

INDICATIONSFOR USE	AVANA Dental Implant Systems are designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium fixture when surgically implanted under controlled conditions, as per well known clinical studies. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
TESTING	Biocompatibility of the AVANA Dental Implant System was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Animal studies were conducted to determine the performance of the surface treatment.
	In-vitro performance tests were conducted to establish device durability as well as to characterize the implant surface treatment and purity. These studies included compression and fatigue tests as well as spectroscopic studies.
SUMMARY OFSUBSTANTIALEQUIVALENCE	The AVANA Dental Implant System is substantially equivalent to the predicate devices in its construction, intended use and principles of operation.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2005

Osstem Company Limited C/O Albert Rego, Ph.D. 27001 La Paz, Suite 312 Mission Viejo, California 92691

Re: K051576

Trade/Device Name: AVANA Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 10, 2005 Received: June 14, 2005

Dear Dr. Rego:

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 - Dr. Rego

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Singite Y. Michael Omd

Chiú 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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OSSTEM CO., LTD. TRADITIONAL 510(K): AVANA DENTAL IMPLANT SYSTEM

Indications for Use Statement

510(k) Number (if known): _ KO 5/ 5760

Device Name:

AVANA Dental Implant System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Suza Qumara

Over the Counter Use

(Division Sign-Off) (Division Sign-Olf)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K051576

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.