The HGIII Ultra wide 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 HGIII Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The HGIII Ultra wide Fixture System is intended to be used in the molar region.

Device Description

The HGIII Ultra wide Fixture System is dental implant made of titanium metal intended to be used in the molar region and surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is RBM, Resorbable Blast Media, treated. HGIII Ultra wide Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has RBM surface.

AI/ML Overview

This 510(k) premarket notification describes a dental implant system (HGIII Ultra wide Fixture System) and its substantial equivalence to a predicate device. This type of submission generally does not include studies demonstrating device performance against specific acceptance criteria in the way an AI/ML device would. Instead, substantial equivalence is established through comparison of design, materials, intended use, and performance characteristics (often non-clinical, such as fatigue testing) to a legally marketed predicate device.

Therefore, many of the requested elements for an AI/ML device study are not directly applicable or available in this document. I will extract the information that is present and indicate where certain information would not be found in this type of submission.

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

This document does not present "acceptance criteria" in the context of clinical performance metrics (like sensitivity, specificity, AUC) that an AI/ML device would need to meet. Instead, it establishes substantial equivalence based on a comparison of characteristics to a predicate device. The performance characteristics are primarily mechanical/material.

Characteristic	Acceptance Criteria (Predicate Device K073465)	Reported Device Performance (HGIII Ultra wide Fixture)
Intended Use	Same as HGII Ultra wide Fixture System (K073465): partially or fully edentulous mandibles and maxillae, supporting various restorations; for single and two-stage surgical procedures; not for immediate load; intended for molar region.	Same as HGII Ultra wide Fixture System (K073465)
Structure	Single Thread, Straight body Type, Self tapping	Single Thread, Taper body Type, Self tapping
Connection Type	Internal hex connection	Internal hex connection
Diameter (D)	6.0~7.0	6.0~7.0
Length (mm)	7.0~13.0	7.0~13.0
Material of Fixture	Pure Titanium Grade 4 (ASTMF67-06)	Pure Titanium Grade 4 (ASTMF67-06)
Surface	RBM	RBM
Packaging	Polymeric Ampoule in a foil backed peel open blister pack	Polymeric Ampoule in a foil backed peel open blister pack
Sterilization	Radiation Sterile	Radiation Sterile
Shelf life	5 years	5 years
S & E (Safety & Effectiveness)	No changes in function and intended use	No changes in function and intended use

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

This submission does not discuss a "test set" in the context of clinical data for performance evaluation. The primary "test" mentioned is non-clinical fatigue testing.

Sample Size for Test Set: Not applicable for clinical performance. For fatigue testing, it's mentioned as "the worst case scenario of the GSIII Fixture(or HGIII Fixture) and an angled abutment". The exact number of samples for this test is not specified in the summary.
Data Provenance: Not applicable for clinical performance. The fatigue testing is likely laboratory-based, performed by the manufacturer, HiOSSEN Inc. (Fairless Hills, PA, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission does not involve human readers establishing ground truth for performance evaluation.

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

Not applicable. There is no multi-reader adjudication for a test set.

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

No MRMC study was done. This is a submission for a dental implant, not an AI/ML device intended to assist human readers.

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

This is not an AI/ML device, so standalone algorithm performance is not applicable.

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

For a physical device like a dental implant, "ground truth" relates to material properties, mechanical integrity, and biocompatibility.

For material properties and dimensions: Standardized measurements and material certifications (e.g., Pure Titanium Grade 4 (ASTMF67-06)).
For functional performance: Non-clinical bench testing (e.g., fatigue testing) against established industry standards and guidance documents ("Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment").
For biocompatibility: Biocompatibility tests performed to comply with applicable International and US regulations.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or ground truth established for it in that context.

Summary

{0}------------------------------------------------

K093889

Image /page/0/Picture/1 description: The image shows the word "HOSSEN" in a bold, sans-serif font. The "O" in "HOSSEN" is stylized with a curved line extending from the top left of the letter. The text is black against a white background.

APR 2 2 2010

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

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

Date : December 4, 2009

Company and Correspondent making the submission:

- Submitter's Name :	HiOSSEN Inc.
- Address :	85 Ben Fairless Dr.Fairless Hills PA 19030
- Telephone No.	888 678 0001
- Contact :	Mr. Patrick Lim
2. Device :

Trade or (Proprietary) Name :	HGIII Ultra wide Fixture System
Common or usual name :	Dental Implant
Classification Name :	Endosseous Dental Implant
	21CFR872.3640
	Class II
	DZE

1. Predicate Device :
  The HG II Ultra wide Fixture System, HiOSSEN Inc, K073465
1. Description :
  I) The HGIII Ultra wide Fixture System is dental implant made of titanium metal intended to be used in the molar region and surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is RBM, Resorbable Blast Media, treated.

HGIII Ultra wide Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has RBM surface.

The HGIII Ultra wide 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.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "HIOSSEN" in a bold, sans-serif font. The letters are black against a white background. The "O" in "HIOSSEN" has a curved line extending from the top of the letter.

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

1. The HGIII Ultra wide Fixture System is substantially equivalent in design, function and intended use to the HG II Ultra wide Fixture System (K073465) of HiOSSEN Inc.

- Substantial Equivalence Matrix

	HGIII Ultra wide Fixture	Predicate devicesHG II Ultra wideFixture (K073465)
Manufacturer	HIOSSEN Inc.	HIOSSEN Inc.
Intended Use	The HGIII Ultra wide FixtureSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple-unitrestorations including ; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework. TheHGIII Ultra wide Fixture Systemis for single and two stagesurgical procedures. It is not forimmediate load. The HGIII Ultrawide Fixture System is intendedto be used in the molar region.	The HG II Ultra wide FixtureSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple-unitrestorations including ; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework. TheHG II Ultra wide Fixture Systemis for single and two stagesurgical procedures. It is not forimmediate load. The HG II Ultrawide Fixture System is intendedto be used in the molar region.
	Structure	-Single Thread-Taper body Type-Self tapping	-Single Thread-Straight body Type-Self tapping
		ConnectionType	Internal hex connection	Internal hex connection
		Diameter (D)	6.0~7.0	6.0~7.0
	Length (mm)	7.0~13.0	7.0~13.0
	Material ofFixture	Pure Titanium Grade 4(ASTMF67-06)	Pure Titanium Grade 4(ASTMF67-06)
	Surface	RBM	RBM
	Packaging	Polymeric Ampoule in a foil backedpeel open blister pack	Polymeric Ampoule in a foil backedpeel open blister pack
		Sterilization	Radiation Sterile	Radiation Sterile
	Shelf life	5 years	5 years
	S & E	No changes in function and intended use

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "Hiossen" in a bold, stylized font. The letters are black against a white background. The "H" is capitalized and the "O" is large and round. There is a curved line above the "O" that connects to the "S".

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

1. Indication for use :
  The HGIII Ultra wide 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 HGIII Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The HGIII Ultra wide Fixture System is intended to be used in the molar region.

6. Review :

The HGIII Ultra wide Fixture System has same material and indication for use and similar design and technological characteristics as the predicate device.

The HGIII Ultra wide 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. Summary of nonclinical testing

Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the GSIII Fixture(or HGIII Fixture) and an angled abutment in support of the HGIII Ultra Wide Fixture. Therefore, the fatigue test result of GSIII Fixture System (or HGM Fixture System) can be used as a proof of HGIII Ultra Wide Fixture since HGIII Ultra Wide Fixture has large diameter.

8. Conclusion :

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

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest wings and a tail. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Patrick Lim Manager Hiossen, Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K093889

Trade/Device Name: HGIII Ultra Wide Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 1, 2010 Received: April 9, 2010

Dear Mr. Lim:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

APR 2 2 2010

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.

{4}------------------------------------------------

Page 2- Mr. Lim

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh fir

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "HlOSSEN" in a stylized font. The letters are bold and slightly distorted, giving the word a unique appearance. The font is sans-serif, and the letters are closely spaced together. The overall impression is one of a modern and slightly playful design.

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 Q 4 38 8 9

Device Name : HGIII Ultra wide Fixture System

Indication for use : The HGIII Ultra wide 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 HGM Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The HGIII Ultra wide Fixture System is intended to be used in the molar region.

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)

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

510(k) Number: K093369

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.