(215 days)
The HIOSSEN Implant 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. ETIII SA Ultra Wide Fixture is intended to be used in the molar region.
The HIOSSEN Implant 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 HIOSSEN Implant System include length 18mm implant. The HIOSSEN Implant System is a revised product that Dimension and code(art#) are changed and added from predicate product, ETII SA Fixture, HTIII SA Fixture and ETIII SA Ultra Wide Fixture therefore there is no difference about material, indication for use and design from predicate as above. And the subject devices and the predicate devices encompass the same range of physical dimensions except length 18mm and characteristics, including implant diameter and surface treatment.
The provided document is a 510(k) premarket notification for the HIOSSEN Implant System. It does not describe a study involving algorithms, AI, or human readers, but rather demonstrates substantial equivalence to predicate devices through non-clinical testing.
Therefore, many of the requested categories related to algorithm performance, expert ground truth, and human-in-the-loop studies are not applicable to this document.
Here's a breakdown of the information that is available in the document:
1. Table of acceptance criteria and reported device performance:
The document describes the HIOSSEN Implant System as substantially equivalent to predicate devices based on various characteristics, primarily focusing on materials, indications for use, and design. The "acceptance criteria" are implied by the comparison to the predicate devices, meaning the new device should not raise new questions of safety and effectiveness regarding these characteristics.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (HIOSSEN Implant System) |
|---|---|---|
| Intended Use | 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. Intended for delayed loading. Ultra-wide Fixture System intended for molar region. | The HIOSSEN Implant 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. ETIII SA Ultra-Wide Fixture is intended to be used in the molar region. (Same as predicate) |
| Structure | Internal Hex-connected, Submerged Fixture, Tapered body shape & Straight body shape. | Internal Hex-connected, Submerged Fixture, Tapered body shape & Straight body shape. (Similar to predicate) |
| Material of Fixture | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) (Same as predicate) |
| Surface | SA surface treatment | SA surface treatment (Same as predicate) |
| Sterilization | Radiation Sterile | Radiation Sterile (Same as predicate) |
| Shelf Life | 5 Years | 8 Years (Improved from predicate; requires justification but does not suggest non-equivalence) |
| Dimensions (Diameter) | Range provided by predicates (e.g., 3.75 - 6.82mm) | HIOSSEN Implant System includes diameters: 3.5, 3.75, 3.77, 4.2, 4.25, 4.45, 4.6, 4.63, 4.65, 4.9, 5.0, 5.05, 5.08, 5.1, 5.92, 5.95, 6, 6.8. Some diameters are modified or added compared to predicates, but stated as encompassing the same range of physical dimensions or being a revised product (e.g., "Diameter is modified," "Diameter is modified/Length 6.2mm is added," "Diameter is modified," etc.). |
| Dimensions (Length) | Range provided by predicates (e.g., 6.2 - 15.2mm) | HIOSSEN Implant System includes lengths: 6.2, 7.2, 8.7, 10.2, 11.7, 13.2, 15.2, 18.2. Length 18.2mm is added for several diameters, and 6.2mm is added for some ultra-wide fixtures. The document states "the subject devices and the predicate devices encompass the same range of physicaldimensions except length 18mm." |
| Performance | Static and dynamic compression-bending in worst-case scenario. | Fatigue testing in air demonstrated the subject device to the tested predicate because shape and minimum diameter of subject devices are the same with predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not applicable. The "test set" in this context refers to non-clinical testing of the physical device. The document mentions "engineering analysis, dimensional analysis, static and dynamic compression-bending testing" and "fatigue testing in air." Specific sample sizes for these tests are not provided in this summary.
- Data provenance: Not applicable. This refers to physical device testing, not data from human subjects or images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This document is for a dental implant system, not an AI/algorithm-based diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for a physical medical device submission.
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:
Not applicable. This is a physical dental implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical dental implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for demonstrating substantial equivalence for this device is based on established engineering standards for medical devices (e.g., ASTM F67 for material, "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" for mechanical testing). The comparison is against predicate devices that have already demonstrated safety and effectiveness.
8. The sample size for the training set:
Not applicable. There is no algorithm or AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no algorithm or AI model requiring a training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12,2014
Mr. Patrick Lim Manager HIOSSEN, Incorporated 85 Ben Fairless Drive Fairless Hills, PA 19030
Re: K140934
Trade/Device Name: HIOSSEN Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 6, 2014 Received: October 10, 2014
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 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/Resourcesfor You/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,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image shows the logo for Hiossen. The logo is composed of the word "Hiossen" in a stylized font. The "H" and "I" are in red, while the rest of the letters are in gray. There is a red swoosh 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
Indications for Use Statement
K140934 510(k) Number K
Device Name : HIOSSEN Implant System
Indication for use :
The HIOSSEN Implant 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. ETIII SA Ultra Wide Fixture is intended to be used in the molar region.
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)
Section 004
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Image /page/3/Picture/0 description: The image shows the Hiossen logo. The "HI" part of the logo is in red, and the "OSSEN" part is in gray. There is a red swoosh above the "HI" part of the logo. The logo is simple and modern.
Section 003
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) substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date : November 15, 2013
- 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 |
-
- Device :
| Trade or (Proprietary) Name : | HIOSSEN Implant System |
|---|---|
| Common or usual name : | Dental Implant |
| Classification Name : | Endosseous Dental Implant21CFR872.3640Class IIDZE. NHA |
- Predicate Device :
HT III SA FIXTURE SYSTEM, HIOSSEN Inc. K101096 ETII SA Fixture System. HiOSSEN Inc.. K123471 ETIII SA Ultra Wide System, HiOSSEN Inc., K103537 TS Implant System, OSSTEM CO., LTD., K121585 HSII Short Fixture System, OSSTEM CO., LTD., K083633 ET SS Implant System, OSSTEM CO., LTD., K120847 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc., K063341
-
- Description :
-
The HIOSSEN Implant 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 HIOSSEN Implant System include length 18mm implant Length 18mm implant has already predicated in K063341, 3i OSSEOTITE® Certain® Dental Implants( Length 7mm~20mm)
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Image /page/4/Picture/0 description: The image shows the logo for HIOSSEN. The letters "HI" are in red, and the rest of the word is in gray. There is a red swoosh above the "HI".
Hiossen Inc.
85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
- ETIII SA Fixture
| DeviceDescription | Intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture issupplied sterile. | ||
|---|---|---|---|
| Material | Pure Titanium (ASTM F 67) | ||
| Surface | SA surface treatment | ||
| Dimension | Diameter (mm) | Length (mm) | added/modified |
| 3.77 | 8.7 | Diameter is modified | |
| 3.75 | 10.2, 11.7, 13.2, 15.2, 18.2 | Length 18.2mm is added | |
| 4.25 | 7.2, 8.7, 10.2, 11.7, 13.2, 15.2, 18.2 | Length 18.2mm is added | |
| 4.65 | 7.2 | None | |
| 4.63 | 8.7 | Diameter is modified | |
| 4.6 | 10.2, 11.7, 13.2, 15.2, 18.2 | Length 18.2mm is added | |
| 5.1 | 6.2, 7.2 | Length 6.2mm is added | |
| 5.08 | 8.7 | None | |
| 5.05 | 10.2, 11.7, 13.2, 15.2 | None |
4) ETIII SA Ultra-Wide Fixture
| DeviceDescription | Intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is supplied sterile. | ||
|---|---|---|---|
| Material | Pure Titanium (ASTM F 67) | ||
| Surface | SA surface treatment | ||
| Dimension | Diameter (mm) | Length (mm) | added/modified |
| 5.95 | 6.2, 9.7 | Diameter is modified/Length 6.2mm is added | |
| 5.92 | 11.2, 12.7 | Diameter is modified | |
| 6 | 7.2, 8.2 | None | |
| 6.8 | 6.2, 7.2, 8.2, 9.7, 11.2, 12.7 | Diameter is modified/Length 6.2mm is added |
5) ETII SA Fixture
| Device | Intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is | ||
|---|---|---|---|
| Description | supplied sterile. | ||
| Material | Pure Titanium (ASTM F 67) | ||
| Surface | SA surface treatment | ||
| Dimension | Diameter (mm) | Length (mm) | added/modified |
| 3.5 | 8.7, 10.2, 11.7, 13.2, 15.2, 18.2 | Length 18.2mm is added | |
| 4.2 | 7.2, 8.7, 10.2, 11.7, 13.2, 15.2, 18.2 | Length 18.2mm is added | |
| 4.45 | 7.2, 8.7, 10.2, 11.7, 13.2, 15.2 | None | |
| 5.0 | 6.2 | None | |
| 4.9 | 7.2, 8.7, 10.2, 11.7, 13.2, 15.2 | None |
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Image /page/5/Picture/0 description: The image shows the word "HIOSSEN" in a stylized font. The "HIO" portion of the word is in red, while the "SSEN" portion is in gray. There is a red swoosh above the "HIO" portion of the word, adding a dynamic element to the logo. The overall design is clean and modern.
Hiossen Inc.
85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
- Cover Screw
| DeviceDescription | Used to protect the exposed platform of the implant during healing period. |
|---|---|
| Material | Pure Titanium (ASTM F 67) |
| Surface | Anodizing |
| diameters | 3.03, 3.58, 3.25, 3.4, 3.75, 3.9 |
| lengths | 5.25, 5.9, 6.25, 6.85, 6.9, 7.5 |
| Change contentas compared tothe predicatedevice | Products code, Art(#)s are changed & Design Change of screw bottom |
7) Healing Abutment
| DeviceDescription | Used to make a soft tissue in a funnel shape before setting up prostheticsand removing cover screw after osseointegration. |
|---|---|
| Material | Pure Titanium (ASTM F 67) |
| Surface | None |
| diameters | 4.3, 4.8, 5.3, 6.3, 7.3 |
| lengths | 7.5, 8.5, 9.5, 11.5, 12.5 |
| Change contentas compared tothe predicatedevice | Addition of Ø4.5mm abutment.Shape of middle part is changed |
- Substantial Equivalence Matrix
| The HIOSSEN ImplantSystem | Predicate devices | ||
|---|---|---|---|
| HTIII SA Fixture/ ETIII SA Ultra WideSystem | ETII SA Fixture System | ||
| 510(K) No. | - | K101096 / K103537 | K123471 |
| Manufacturer | HIOSSEN Inc. | HIOSSEN Inc. | HIOSSEN Inc. |
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Image /page/6/Picture/0 description: The image shows the word "HIOSSEN" in a stylized font. The "HI" is in red, and the rest of the word is in gray. There is a red swoosh above the "HI".
Section 003
Hiossen Inc.
85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
| Design | |||
|---|---|---|---|
| IntendedUse | The HIOSSEN ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple-unit restorations including:cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutment supportfor fixed bridgework. It isintended for delayed loading.ETIII SA Ultra-Wide Fixtureis intended to be used in themolar region. | The HTIII Fixture System isindicated for use in partiallyor fully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutment supportfor fixed bridgework. It isintended for delayed loading.Ultra wide Fixture System isintended to be used in themolar region. | The ETII Fixture System isindicated for use in partiallyor fully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including:cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutment supportfor fixed bridgework. It isintended for delayed loading. |
| Structure | - Internal Hex-connected- Submerged Fixture- Tapered body shape &Straight body shape | - Internal Hex-connected- Submerged Fixture- Tapered body shape &Straight body shape | - Internal Hex-connected- Submerged Fixture- Straight body shape |
| Diameter (D) | 3.5, 3.75, 3.77, 4.2, 4.25, 4.45,4.6, 4.63, 4.65, 4.9, 5.0,5.05, 5.08, 5.1, 5.92, 5.95, 6,6.8 | 3.75, 4.25, 4.6, 5.05, 5.08,5.1, 6, 5.92, 5.95, 6.8, 6.82 | 3.5, 4.2, 4.45, 4.9, 5.0 |
| Length (mm) | 6.2, 7.2, 8.7, 10.2, 11.7, 13.2,15.2, 18.2 | 7.2, 8.7, 10.2, 11.7, 13.2, 15.2 | 6.2, 7.2, 8.7, 10.2, 11.7, 13.2,15.2 |
| Material ofFixture | Pure Titanium Grade 4(ASTM F67) | Pure Titanium Grade 4(ASTM F67) | Pure Titanium Grade 4(ASTM F67) |
| Surface | SA | SA | SA |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Shelf life | 8 Years | 5 Years | 5 Years |
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Image /page/7/Picture/0 description: The image contains the logo for HIOSSEN. The logo is composed of the letters "HIOSSEN" in a stylized font. The "HI" portion of the logo is in red, while the "OSSEN" portion is in gray. The "H" and "I" are connected by a red swoosh.
Hiossen Inc.
85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
| SE | The HIOSSEN Implant System is revised product that Dimension and code(art#) are changedand added from predicate product, ETII SA Fixture, HTIII SA Fixture and ETIII SA Ultra WideFixture therefore there is no difference about material, indication for use and design frompredicate as aboveAnd the subject devices and the predicate devices encompass the same range of physicaldimensions except length 18mm and characteristics, including implant diameter and surfacetreatment therefore The HIOSSEN Implant System is substantially equivalent to the predicatedevices |
|---|---|
| ---- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
5. Indication for use :
The HIOSSEN Implant 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. ETIII SA Ultra-Wide Fixture is intended to be used in the molar region.
6. Review :
The HIOSSEN Implant System has same material, indication for use, similar design and technological characteristics as the predicate device.
7. Summary of nonclinical testing
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to "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. Fatigue testing in air demonstrated the subject device to the tested predicate because shape and minimum diameter of subject devices are the same with predicate.
8. 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 The HIOSSEN Implant System is substantially equivalent to the predicate devices as described herein
§ 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.