(171 days)
The HT III SA 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 HT III SA Fixture System is for single and two stage surgical procedures. It is not for immediate load.
- The HTⅢ SA Fixture System is dental implant made of titanium metal intended to The 111m of I hitalie byelom of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
- HTⅢ SA Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has SA surface.
- The HTII SA 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 provided text is a 510(k) summary for a dental implant system (HTIII SA Fixture System) seeking substantial equivalence to existing predicate devices. It does not describe any acceptance criteria or a study proving device performance against such criteria in the context of an AI/human comparative effectiveness study or a standalone algorithm performance study.
Instead, this document focuses on demonstrating substantial equivalence through comparisons of:
- Intended Use: The HTIII SA Fixture System is used in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations, and for single and two-stage surgical procedures (not for immediate load). This is directly compared to the predicate HGIII Fixture System, which has identical intended use, and generally aligns with the Straumann Standard Implant.
- Design and Technology: It highlights features like single threads, taper body type, self-tapping, submerged fixture, and internal hex connection, stating it's similar to the predicate HGIII Fixture System.
- Material: The device is made of Pure Titanium Grade 4 (ASTM F67-06), identical to both predicate devices.
- Surface Treatment: While the HTIII SA Fixture uses "SA" surface treatment, the predicate HGIII uses "RBM", and the Straumann Standard Implant uses "SLA". The document states the HTIII SA Fixture's surface treatment is "similar" to the Straumann Standard Implant.
- Biocompatibility and Safety: Biocompatibility tests were conducted according to ISO 10993 standards (ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, and ISO 10993-11), and surface treatment tests were performed. The results were found to be similar to previously cleared predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, or AI study details because this document pertains to a medical device (dental implant) and its regulatory clearance process, not an AI or diagnostic imaging device involving performance metrics like sensitivity, specificity, or reader studies.
The "study" referenced in this document is a series of non-clinical tests (biocompatibility and surface treatment) demonstrating the device's safety and performance characteristics are similar to predicate devices, thereby supporting its substantial equivalence for regulatory clearance.
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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) Summary
OCT 8 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date : April 6th, 2010
- Company and Correspondent making the submission:
- Submitter's Name :
HiOSSEN Inc.
888 678 0001
Mr. Patrick Lim
85 Ben Fairless Dr.
Fairless Hills PA 19030
-
Address :
-
Telephone No.
-
Contact : .
- Device :
Trade or (Proprietary) Name : Common or usual name : Classification Name :
HTM SA Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE
3. Predicate Device :
The HGI Fixture System, HiOSSEN Inc, K093352 The Straumann Standard Implant, Institut Straumann Ag, K061176
4. Description :
-
The HTⅢ SA Fixture System is dental implant made of titanium metal intended to The 111m of I hitalie byelom of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
-
HTⅢ SA Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has SA surface.
-
The HTII SA 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.
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Image /page/1/Picture/1 description: The image shows the word "Hiossen" in a stylized, bold font. The "H" is a standard block letter, while the "i" has a curved extension over the "o". The letters are all connected and slanted slightly to the right, giving the word a dynamic appearance. The overall impression is a strong and modern brand name.
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
| · Substantial Equivalence Matrix | ||
|---|---|---|
| HTIII SA Fixture | Predicate devicesHGIII Fixture (K093352) | Straumann StandardImplant (K061176) | |
|---|---|---|---|
| Manufacturer | HIOSSEN Inc. | HIOSSEN Inc. | Institut Straumann Ag |
| IntendedUse | The HTIII SA FixtureSystem is indicated for usein partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including ;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate abutmentsupport for fixedbridgework. The HTIII SAFixture System is for singleand two stage surgicalprocedures. It is not forimmediate load. | The HGIII FixtureSystem is indicated for usein partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including ;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate abutmentsupport for fixedbridgework. The HGIIIFixture System is for singleand two stage surgicalprocedures. It is not forimmediate load. The Ultrawide Fixture System isintended to be used inthe molar region. | Straumann Regular Neckand Narrow Neck implantsare intended for immediateplacement and function onsingle-tooth and/or multipletooth applications whengood primary stability isachieved, with appropriateocclusal loading, in order torestore chewing function.Multiple tooth applicationsmay be rigidly splinted. Inthe case of edentulouspatients, four or moreimplants must be used.The Straumann RegularNeck Implants are intendedfor surgical placement inthe maxillary and/ormandibular arches toprovide support forprosthetic restorationsin edentulous or partiallyedentulous patients forsingle-stage or two-stagesurgery. The StraumannNarrow Neck implants areintended for surgicalplacement in the maxilla ormandible to serve as a basefor prostheticreconstructions.Specifically, the NarrowNeck implant is indicatedfor replacement of singlelateral incisors in themaxilla and lateral andcentral incisors in the |
| mandible. It is particularlyintended for those areaswhere the interdental spaceis extremely limited(minimum 5 mm) andwhere vestibule-oral bone isrestricted (minimum 5 mm).The Narrow Neck implantcan also be used as asupport for a full archimplant-born restoration,but only in conjunction witha standard Straumann 4.1mm dental implant. | |||
| Structure | -Single Thread-Taper body Type-Self tapping-Submerged fixture | -Single Thread-Taper body Type-Self tapping-Submerged fixture | -Single Thread-Straight body Type-Non-submerged fixture |
| ConnectionType | Internal hex connection | Internal hex connection | Internal connection |
| Diameter (D)*Length (mm) | Refer to the Table 1 | ||
| Material ofFixture | Pure Titanium Grade 4(ASTMF67-06) | Pure Titanium Grade 4(ASTMF67-06) | Pure Titanium Grade 4(ASTMF67-06) |
| Surface | SA | RBM | SLA |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Shelf life | 5 years | 5 years | 5 years |
| S & E | The HTⅢ SA Fixture System has same material, indication for use and design as theHGⅢ Fixture System. But they have different surface treatment. The HTⅢ SA FixtureSystem has similar surface treatment as the Straumann Standard Implant. |
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Image /page/2/Picture/1 description: The image shows the word "HlOSSEN" in a bold, sans-serif font. The "H" is capitalized and slightly larger than the other letters. There is a horizontal line running through the middle of the word, which appears to be a printing artifact. The overall impression is of a logo or brand name.
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004
-
- Indication for use :
The HT III SA 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, and maxnike, in bappen of estorations, and terminal or intermediate abutment support for Serew readined, or over III SA Fixture System is for single and two stage surgical procedures. It is not for immediate load.
- Indication for use :
-
- Review :
The HTII SA Fixture System has same material and indication for use and similar design and technological characteristics as the predicate device.
- Review :
The HTⅢ SA Fixture System has been subjected to safety, performance, and product TIK TTT OF I Intare by tests including biocompatibility have been performed to vinuations prior to remply with the applicable International and US regulations.
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Image /page/3/Picture/1 description: The image shows the word "Hiossen" in a stylized, bold font. The letters are black and appear to be slightly distorted, with some horizontal lines running through them. The font has a unique design, particularly the "H" and the curved line above the "o".
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
-
- Summary of nonclinical testing
The biocompatibility test was conducted according to ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO 10993-11. The surface treatment test was conducted. The biocompatibility and surface treatment test results were similar to previously cleared predicate device.
- Summary of nonclinical testing
-
- Conclusion :
Based on the information provided in this premarket notification HiOSSEN concludes that the HTM SA Fixture System is substantially equivalent to the predicate device as described herein.
- Conclusion :
| HTII SA Fixture | Predicate devices | ||||
|---|---|---|---|---|---|
| HGII Fixture (K093352) | Straumann StandardImplant (K061176) | ||||
| (Ø) | (mm) | (Ø) | (mm) | (Ø) | (mm) |
| 3.75 | 8.7, 10.2, 11.7,13.2, 15.2 | 3.75 | 8.7, 10.2, 11.7,13.2, 15.2 | 3.3 | 8.0, 10.0, 12.0,14.0, 16.0 |
| 4.25 | 7.2, 8.7, 10.2,11.7, 13.2,15.2 | 4.25 | 7.2, 8.7, 10.2,11.7, 13.2,15.2 | 4.1 | 6.0, 8.0, 10.0,12.0, 14.0,16.0 |
| 4.6, 4.63,4.65 | 7.2, 8.7, 10.2,11.7, 13.2,15.2 | 4.6, 4.63,4.65 | 7.2, 8.7, 10.2,11.7, 13.2,15.2 | 4.8 | 6.0, 8.0, 10.0,12.0, 14.0 |
| 5.05, 5.08,5.1 | 7.2, 8.7, 10.2,11.7, 13.2,15.2 | 5.05, 5.08,5.1 | 7.2, 8.7, 10.2,11.7, 13.2,15.2 | 4.8 | 6.0, 8.0,10.0, 12.0 |
Table 1. Diameter and length (HT3 SA Fixture and Predicate devices)
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread, symbolizing protection and service. The eagle is depicted in a simple, abstract manner.
일: 2017-0
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
8 2010
Re: K101096
Trade/Device Name: HTIII SA Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 29, 2010 Received: September 29, 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.
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- 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. 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
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Image /page/6/Picture/0 description: The image shows the word "HOSSEN" in a stylized font. The letters are black and have a textured appearance, as if they were created with a grainy or speckled effect. There is a horizontal line running through the middle of the word, and a curved line above the first "S", adding to the unique design of the text.
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 JO1096
Device Name : HTⅢ SA Fixture System
Indication for use : The HT III SA 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 HT III SA Fixture System is for single and two stage surgical procedures. It is not for immediate load.
X Prescription Use_ (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)
Nichol Miller
(Division Sign-Off) Division of Anesthesiology, General Hoapital Infection Control, Dental Devices
510(k) Number: 101096
§ 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.