(98 days)
Not Found
No
The document describes a dental implant and its components, focusing on material, design, and mechanical testing. There is no mention of AI or ML technology.
Yes
The device is a dental implant used for restoring edentulous mandibles and maxillae, which directly addresses a medical condition.
No
This device is a dental implant (ETIII SA Ultra wide Fixture) designed for surgical placement in the bone for tooth restoration, not for diagnosing conditions.
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 text, 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.
- Device Description: The description clearly states the device is a "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."
- Intended Use: The intended use is for supporting dental restorations in partially or fully edentulous mandibles and maxillae.
The device is a surgically implanted medical device, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The ETII SA Ultra wide 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 ETII SA Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The ETII SA Ultra wide Fixture System is intended to be used in the molar region.
Product codes
DZE, NHA
Device Description
The ETⅢ SA Ultra wide Fixture 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 ETM SA Ultra wide Fixture is composed of single threads with internal hex connection taper body of bone level. The surface is SA, Sandblasting and Acid etching, treated.
The ET Healing Abutment is used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae, molar region
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 GS III Fixture(or HGII Fixture) and an angled abutment in support of the ETIII SA Ultra Wide Fixture. Therefore, the fatigue test result of GSIII Fixture System (or HGIII Fixture System) can be used as a proof of ETIII SA Ultra Wide Fixture since ETIII SA Ultra Wide Fixture has large diameter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the word "Hiossen" in a stylized font. The letters are black and have a slightly distressed or textured appearance. The "H" is capitalized and bold, and there is a 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 510(k) Summary
MAR 10 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date : Nov 11th, 2010
- Company and Correspondent making the submission:
- Submitter's Name :
HiOSSEN Inc.
85 Ben Fairless Dr.
- Address :
Fairless Hills PA 19030 888 678 0001
Mr. Patrick Lim
-
Telephone No.
-
Contact :
-
- Device :
Trade or (Proprietary) Name : Common or usual name : Classification Name :
ETII SA Ultra wide System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE
4. Description :
-
- The ETⅢ SA Ultra wide Fixture 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 ETM SA Ultra wide Fixture is composed of single threads with internal hex connection taper body of bone level. The surface is SA, Sandblasting and Acid etching, treated.
-
- The ET Healing Abutment is used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration.
UD-L-001
1
Image /page/1/Picture/1 description: The image shows the word "HOSSEN" in a stylized font. The "H" and the top of the "O" are in bold black, while the rest of the letters are outlined. 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 www.hiossen.com
Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the GS III Fixture(or HGII Fixture) and an angled abutment in support of the ETIII SA Ultra Wide Fixture. Therefore, the fatigue test result of GSIII Fixture System (or HGIII Fixture System) can be used as a proof of ETIII SA Ultra Wide Fixture since ETIII SA Ultra Wide Fixture has large diameter.
8. Conclusion :
Based on the information provided in this premarket notification HiOSSEN concludes that the ETII SA Ultra wide System is substantially equivalent to the predicate device as described herein.
2
Image /page/2/Picture/1 description: The image shows the logo for Hiossen Inc. The logo is in black and white and features the word "Hiossen" in a stylized font. The "H" is bold and solid, while the rest of the letters are outlined. There is a curved line above the "H" that adds a dynamic element to the logo. Below the word "Hiossen" is the text "Hiossen Inc."
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
-
- The ETIII SA Ultra wide System is same to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
| | ETⅢ SA Ultra wide
Fixture | Predicate devices | |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | HGⅢ Ultra wide Fixture | ETⅢ SA Fixture |
| Manufacturer | Hiossen Inc | Hiossen Inc | Hiossen Inc |
| 510(k) Number | New | K093889 | K101096 |
| Design | Image: ETIII SA Ultra wide Fixture | Image: HGIII Ultra wide Fixture | Image: ETIII SA Fixture |
| Indication
for use &
Procedural
Precautions | The ETⅢ SA Ultra wide
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 ETⅢ
Ultra wide System is for
single and two stage
surgical procedures. It is
not for immediate load.
The HGⅢ Ultra wide
System is intended to be
used in the molar region. | 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. | The ETⅢ 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 ETⅢ SA
Fixture System is for single
and two stage surgical
procedures. It is not for
immediate load. |
- Substantial Equivalence Matrix
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Image /page/3/Picture/1 description: The image shows the word "HOSSEN" in a stylized font. The letters are black, with the exception of the "O"s, which are outlined. A curved line extends from the top of the "H" over the first "O". The letters have a slightly textured appearance.
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills. PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
Diameter (D) Refer to the Table 1 *Length (mm) Material of Pure Titanium Grade 4 Pure Titanium Grade 4 Pure Titanium Grade 4 Fixture (ASTMF67-06) (ASTMF67-06) (ASTMF67-06) SA (Sandblasting and Acid SA (Sandblasting and Acid Surface RBM Treatment etching) (Resorbable Blast Media) etching) Polymeric Ampoule in a Polymeric Ampoule in a Polymeric Ampoule in a foil backed peel open Packaging foil backed peel open foil backed peel open blister pack blister pack blister pack Sterilization Radiation Sterile Radiation Sterile Radiation Sterile Shelf life 5 years 5 years 5 years
| ETIII SA Ultra wide Fixture | Predicate devices | ||||
|---|---|---|---|---|---|
| (Ø) | (mm) | HGIII Ultra wide Fixture | |||
| (Ø) | (mm) | ETIII SA Fixture | |||
| (Ø) | (mm) | ||||
| - | - | - | - | 3.75 | 8.7, 10.2, 11.7, |
| 13.2, 15.2 | |||||
| - | - | - | - | 4.25 | 7.2, 8.7, 10.2, |
| 11.7, 13.2, 15.2 | |||||
| - | - | - | - | 4.6, 4.65 | 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 | |||||
| 5.9, 5.92, 6.0 | 7.2, 8.2, 9.7, | ||||
| 11.2, 12.7 | 5.9, 5.92, 6.0 | 7.2, 8.2, 9.7, | |||
| 11.2, 12.7 | - | - | |||
| 6.8, 6.82 | 7.2, 8.2, 9.7, | ||||
| 11.2, 12.7 | 6.8, 6.82 | 7.2, 8.2, 9.7, | |||
| 11.2, 12.7 | - | - |
Table 1. Diameter and length (ETII SA Ultra wide Fixture and Predicate devices)
-
- Indication for use :
The ETII SA Ultra wide 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 ETIII SA Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The ETIII SA Ultra wide Fixture System is intended to be used in the molar region.
- Indication for use :
-
- Review :
The ETII SA Ultra wide System has same material, indication for use and technological characteristics as the predicate device.
- Review :
The ETIII SA Ultra wide 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.
-
- Summary of nonclinical testing
Fatigue testing was conducted according to the "Guidance for industry and FDA staff
- Summary of nonclinical testing
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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 and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Patrick Lim Regulatory Affairs HiOSSEN Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
MAR 1 0 2011
Re: K103537
Trade/Device Name: ETIII SA Ultra wide System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 7, 2011 Received: February 8, 2011
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 (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
f Susan Ruones
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 "Hiossen" in a stylized font. The "H" and "I" are in bold black font, while the rest of the letters are outlined. There is a curved line above the "O" in "Hiossen."
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 103537
Device Name : ETII SA Ultra wide System
Indication for use : The ETII SA Ultra wide 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 ETII SA Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The ETII SA 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)
Office of Business Evaluation (SBE)
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division Control, Dental Devices
510(k) Number: K103537