The HG II Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Device Description

The HG II Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

AI/ML Overview

This document is a 510(k) summary for the Hiossen HG II Fixture System, a dental implant. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated study proving performance against general acceptance criteria for such a device.

Therefore, many of the requested categories of information are not present in this type of regulatory submission. The document explicitly states: "The HG II Fixture System is substantially equivalent in design, function and intended use to the HG II Fixture System (K080744) of Osstem Implant Co., Ltd."

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

1. A table of acceptance criteria and the reported device performance

This document does not define specific "acceptance criteria" for the device's performance in a quantitative or qualitative manner that would typically be found in a study or a validation report outlining specific metrics (e.g., strength, biocompatibility thresholds). Instead, it states the device has undergone general safety and performance validations.

Acceptance Criterion	Reported Device Performance
Safety and Performance	"The HG II Fixture System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations."
Material Composition	"same material as the predicate device"
Indication for Use	"same indication for use as the predicate device"
Design and Technological Characteristics	"similar design and technological characteristics as the predicate device"
Substantial Equivalence	"safe and effective and substantially equivalent to the predicate device as described herein"

Note: The "acceptance criteria" here are inferred from the statements made for regulatory clearance, rather than explicit, quantifiable metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in the document. The document refers to "safety, performance, and product validations" but does not detail the sample sizes, study design (retrospective/prospective), or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a 510(k) summary for device clearance, not a study evaluating human or AI performance against a ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a 510(k) summary for device clearance, not a study involving expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is for a dental implant system. There is no mention of AI assistance or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document is for a physical medical device (dental implant), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The document relies on demonstrating substantial equivalence to a predicate device, supported by safety and performance validations, rather than establishing a new ground truth for a diagnostic task. The "ground truth" for regulatory clearance is that the device meets safety and effectiveness requirements and is substantially equivalent to a legally marketed predicate.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. This is a physical device, not an AI model.

Summary

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Image /page/0/Picture/0 description: The image shows the word "HOSSEN" in a stylized font. The letters are bold and black, with a slightly distressed texture. The "O" in "HOSSEN" is particularly large and round, and there is a curved line above the word, starting from the "H" and extending over the first "S".

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com 510(k) Summary

K090237

APR 1 7 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date : January 23, 2009

Company and Correspondent making the submission:

Submitter's Name :

HiOSSEN Inc.

Mr. MinJoo Kim

Address :

85 Ben Fairless Dr.

Fairless Hills PA 19030

Address :
Contact :
1. Device :
  Trade or (Proprietary) Name : Common or usual name :

Classification Name :

HG II Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

3. Predicate Device :

The HG II Fixture System, Osstem Implant Co., Ltd, K080744

1. Description :
  The HG II Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

The HG II Fixture System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The HG II Fixture System is substantially equivalent in design, function and intended use to the HG II Fixture System (K080744) of Osstem Implant Co., Ltd.

5. Indication for use :

The HG II Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained,

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Image /page/1/Picture/0 description: The image shows the word "HOSSEN" in a stylized font. The letters are bold and black, with a slightly distressed or textured appearance. The "H" is capitalized, and there is a curved line extending from the top of the "T", adding a unique design element to the word.

Hiossen Inc.

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004

www.hiossen.com

screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load.

6. Review :

The HG II Fixture System has same material and indication for use and similar design and technological characteristics as the predicate device.

The HG II Fixture System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

7. Conclusion :

Based on the information provided in this premarket notification HiOSSEN concludes that the HG II Fixture System is safe and effective and substantially equivalent to the predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching what appears to be a caduceus or a similar symbol representing health and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Minjoo, Kim Manager Hiossen Incorporated 85 Ben Fairless Drive Fairless Hill, Pennsylvania 19030

APR 1 7 2009

Re: K090237

Trade/Device Name: HG II Fixture System Regulation Number: 872.3640 Regulatory Class: II Product Code: DZE Dated: January 23, 2009 Received: February 2, 2009

Dear Mr. Kim:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2- Mr. Kim

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0100. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sween Rioner

Susan Runner, D.D.S., M.A. Acting 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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Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com 510(k) Number K

Device Name: HG II Fixture System

Indication for use : The HG II Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Prescription Use X (Per 21CFR801 Subpart D) OR

Over-The-Counter Use (Per 21CFR807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rapper

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

510(k) Number: K090237

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.