(234 days)
No
The document describes a dental implant made of titanium with a specific surface treatment and design. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are based on fatigue testing of the physical device.
No.
A therapeutic device is one that treats a disease or condition. This device is a dental implant used to support restorations, which is a reconstructive and supportive function, not a therapeutic one in the sense of treating an active disease.
No
The device is a dental implant system used for supporting dental restorations, not for diagnosing medical conditions.
No
The device description explicitly states it is a dental implant made of titanium metal intended for surgical placement, which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The ETII SA Fixture system is a dental implant designed to be surgically placed inside the body (in the jawbone). It is a physical implant, not a test or a device used to analyze samples.
- Intended Use: The intended use is to support dental restorations in the mouth, which is an in-vivo (within the body) application.
The description clearly indicates a surgically implanted device, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ETII 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
Product codes
DZE
Device Description
The ETII SA Fixture System is dental implant made of titanium metal intended to be 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 SA, Sandblasting and Acid etching, treated.
ETII SA Fixture is composed of single threads with internal hex connection straight body of bone level for two stage surgery. It has SA surface. The ETII SA Fixture System is for single and two stage surgical procedures.
ETII SA Fixture System is compatibly used with abutment in the ET/SS Implant System (K120847)
The ETII 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 ETII SA Fixture is available in various lengths and diameters according to the anatomical situation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Fatigue testing was considered 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 HGII Fixture and an angled abutment in support of the ETII SA Fixture.
ETII SA Fixture System has same material and similar design as the HGII Fixture. Therefore, the fatigue test result of HGII Fixture can be used as a proof of ETII SA Fixture System.
No clinical studies are submitted.
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
12247
5 2013 JUL
Image /page/0/Picture/2 description: The image shows the word "Hiossen" in a stylized font. The letters are black and have a textured appearance. The "H" is capitalized and slightly larger than the other letters. The "i" has a curved line extending from the top, 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
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 : October 10, 2012
- Company and Correspondent making the submission:
- Submitter's Name :
HiOSSEN Inc.
888 678 0001
Mr. Patrick Lim
- Address :
85 Ben Fairless Dr. Fairless Hills PA 19030
-
Telephone No.
-
Contact :
- Device :
Trade or (Proprietary) Name : Common or usual name : Classification Name :
ETII SA Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE
- Predicate Device :
The ET III SA FIXTURE SYSTEM, HIOSSEN Inc, K101096 The HGII Fixture system, HIOSSEN Inc, K090237 The HG II Short Fixture System, OSSTEM CO., LTD, K091678
- Description :
I) The ETII SA Fixture System is dental implant made of titanium metal intended to be 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 SA, Sandblasting and Acid etching, treated.
- ETII SA Fixture is composed of single threads with internal hex connection straight body of bone level for two stage surgery. It has SA surface. The ETII SA Fixture System is for single and two stage surgical procedures.
1
Image /page/1/Picture/1 description: The image shows the word "OSSEN" in a stylized font. The letters are bold and slightly slanted to the right. The letter "T" has an extended curved top, giving it a unique appearance.
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
-
- ETII SA Fixture System is compatibly used with abutment in the ET/SS Implant System (K120847)
-
- The ETII 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 ETII SA Fixture is available in various lengths and diameters according to the anatomical situation.
| diameter | lengths |
|---|---|
| 3.5mm | 8.7mm, 10.2mm, 11.7mm, 13.2mm, 15.2mm |
| 4.2mm | 7.2mm, 8.7mm, 10.2mm, 11.7mm, 13.2mm, 15.2mm |
| 4.45mm | 7.2mm, 8.7mm, 10.2mm, 11.7mm, 13.2mm, 15.2mm |
| 5.0mm | 6.2mm |
| 4.9mm | 7.2mm, 8.7mm, 10.2mm, 11.7mm, 13.2mm, 15.2mm |
- Substantial Equivalence Matrix
| | ETII SA Fixture
System | Predicate devices | | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | ET III SA Fixture
system | HGII Fixture
system | HG II Short
Fixture System |
| 510(K) No. | - | K101096 | K090237 | K091678 |
| Manufacturer | HIOSSEN Inc. | HIOSSEN Inc. | HIOSSEN Inc. | OSSTEM
IMPLANT CO.,
LTD. |
| Design | Image: ETII SA Fixture System Design | Image: ET III SA Fixture system Design | Image: HGII Fixture system Design | Image: HG II Short Fixture System Design |
| Intended
Use | The ETII SA
Fixture system is
indicated for use in
partially or fully
edentulous
mandibles and
maxillae, in support | ET III SA Fixture
System is indicated
for use in partially
or fully
edentulous
mandibles and
maxillae, in support | The HG II Fixture
System is indicated
for use in partially
or fully edentulous
mandibles and
maxillae, in support
of single or | The HG II Short
Fixture
System is intended
for use in
partially or fully
edentulous
mandibles and |
| | of single or
multiple-unit
restorations
including; cemented
retained, screw
retained, or
overdenture
restorations, and
final or temporary
abutment support
for fixed
bridgework. It is
intended for delayed
loading. Ultra wide
Fixture System is
intended to be used
in the molar region. | of single or
multiple-unit
restorations
including:
cemented retained,
screw retained, or
overdenture
restorations, and
terminal or
intermediate
abutment
support for fixed
bridgework. The
ETIII SA 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. | 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. | 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. It is not
for immediate load. |
| Structure | - Straight body
Type
-Self tapping
-Submerged fixture
- ETII SA Fixture
System is for single
and two stage
surgical procedures. | -Taper body Type
-Self tapping
-Submerged fixture - ETIII SA Fixture
System is for single
and two stage
surgical procedures. | - Straight body
Type
-Self tapping
-Submerged fixture | - Straight body
Type
-Self tapping
-Submerged fixture |
| Connection
Type | Internal hex
connection | Internal hex
connection | Internal hex
connection | Internal hex
connection |
| Diameter (D) | 3.5, 4.2, 4.45, 4.9,
5.0 | 3.755.05 | 3.54.85 | 4.856.85 |15.2 | 7.2~15.2 | 6.2 |
| Length (mm) | 6.2, 7.2, 8.7, 10.2,
11.7, 13.2, 15.2 | 7.2
| Material of
Fixture | Pure Titanium
Grade 4
(ASTMF67-06) | Pure Titanium
Grade 4
(ASTMF67-06) | Pure Titanium
Grade 4
(ASTMF67-06) | Pure Titanium
Grade 4
(ASTMF67-06) |
| Surface | SA | SA | RBM | RBM |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Shelf life | 5 years | 5 years | 5 years | 5 years |
| SE | The ETII SA Fixture System has same material, indication for use and surface treatment
as predicate device such as above and there are no big differences between design of ETII
SA Fixture System and predicate device, especially ETII SA Fixture System is almost the
same with HGII Fixture system except thread shape of the top | | | |
2
长123471
Image /page/2/Picture/1 description: The image shows the word "HIOSSEN" in a bold, sans-serif font. The letters are black and slightly distressed, giving them a textured appearance. The word appears to be 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
3
Image /page/3/Picture/1 description: The image shows the word "Hiossen" in a stylized, bold font. The letters are black and slightly distorted, giving them a textured appearance. The "H" and "i" are connected, and there is a curved line above the "i" that extends over the "O".
85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
-
- Indication for use :
ETII 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
- Indication for use :
6. Review :
The ETII SA Fixture System has same material and indication for use and similar design and technological characteristics as the predicate device.
The ETII SA 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 considered 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 HGII Fixture and an angled abutment in support of the ETII SA Fixture.
ETII SA Fixture System has same material and similar design as the HGII Fixture. Therefore, the fatigue test result of HGII Fixture can be used as a proof of ETII SA Fixture System
-
- Summary of clinical testing No clinical studies are submitted
9. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification HiOSSEN Inc. concludes that the ETII SA Fixture System is substantially equivalent to the predicate devices as described herein
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 5, 2013
Mr. Patrick Lim Manager Hiossen, Incorporated 85 Ben Fairless Drive FAIRLESS HILLS PA 19030
Re: K123471
Trade/Device Name: ETII SA Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 10, 2013 Received: May 15, 2013
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
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Lester W. Schultheis Jr 2013.07 05 12
Acting for Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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 "H" and "I" are in solid black, while the rest of the letters are outlined with a textured fill. A curved line extends from the top of the "H" over the "I", adding a decorative element to the word.
Hiossen Inc. 85 Ben Falrless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
510(k) Number K | 123471
Device Name : ETII SA Fixture System
Indication for use :
The ETII 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
| Prescription Use | X |
|---|---|
| (Per 21CFR801 Subpart D) |
Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green 2013.07.02 13:23:25 04
for M.Susan Runner, DDS, MA
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number:
UD-L-001