(171 days)
No
The document describes a dental implant system made of titanium with a specific surface treatment. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies. The performance studies focus on biocompatibility and surface treatment, not algorithmic performance.
Yes
The device is a dental implant system used for supporting single or multiple-unit restorations in edentulous mandibles and maxillae, addressing a medical condition (edentulism) by replacing missing teeth.
No
The device is described as a dental implant system (HT III SA Fixture System) used to support restorations in edentulous mandibles and maxillae. Its intended use and description focus on aiding in structural support and restoration, not on diagnosing medical conditions or diseases.
No
The device description explicitly states it is a dental implant made of titanium metal, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for supporting dental restorations in the mouth (mandibles and maxillae). This is a surgical and prosthetic application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a dental implant made of titanium, designed to be surgically placed in bone. This is a physical implant, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a medical device used for surgical and restorative purposes within the body.
N/A
Intended Use / Indications for Use
The HTIII 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 HTIII SA Fixture System is for single and two stage surgical procedures. It is not for immediate load.
Product codes
DZE
Device 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 HTIII 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The HTII 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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 devices
HGIII Fixture (K093352) | Straumann Standard
Implant (K061176) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | HIOSSEN Inc. | HIOSSEN Inc. | Institut Straumann Ag |
| Intended
Use | The HTIII 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 HTIII SA
Fixture System is for single
and two stage surgical
procedures. It is not for
immediate load. | The HGIII 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
Fixture System is for single
and two stage surgical
procedures. It is not for
immediate load. The Ultra
wide Fixture System is
intended to be used in
the molar region. | Straumann Regular Neck
and Narrow Neck implants
are intended for immediate
placement and function on
single-tooth and/or multiple
tooth applications when
good primary stability is
achieved, with appropriate
occlusal loading, in order to
restore chewing function.
Multiple tooth applications
may be rigidly splinted. In
the case of edentulous
patients, four or more
implants must be used.
The Straumann Regular
Neck Implants are intended
for surgical placement in
the maxillary and/or
mandibular arches to
provide support for
prosthetic restorations
in edentulous or partially
edentulous patients for
single-stage or two-stage
surgery. The Straumann
Narrow Neck implants are
intended for surgical
placement in the maxilla or
mandible to serve as a base
for prosthetic
reconstructions.
Specifically, the Narrow
Neck implant is indicated
for replacement of single
lateral incisors in the
maxilla and lateral and
central incisors in the |
| | | | mandible. It is particularly
intended for those areas
where the interdental space
is extremely limited
(minimum 5 mm) and
where vestibule-oral bone is
restricted (minimum 5 mm).
The Narrow Neck implant
can also be used as a
support for a full arch
implant-born restoration,
but only in conjunction with
a standard Straumann 4.1
mm 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 |
| Connection
Type | Internal hex connection | Internal hex connection | Internal connection |
| Diameter (D)
*Length (mm) | Refer to the Table 1 | | |
| Material of
Fixture | 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 the
HGⅢ Fixture System. But they have different surface treatment. The HTⅢ SA Fixture
System has similar surface treatment as the Straumann Standard Implant. | | |
2
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.
3
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 Standard | ||||
| Implant (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)
4
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.
5
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
6
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