(417 days)
The EK Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is indicated for delayed loading. Ultra wide versions are indicated for use in the molar region only.
The EK Dental Implants (Ø3.5mm) are made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The EK Dental Implants (Ø3.5mm) are indicated for use in mandibular and maxillary lateral and central incisor, 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.
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
The EK Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches, providing support to prosthetic devices to restore normal chewing functions. There are two types: SA and NH, both are bone level implants with the exact same internal hex, tapered body, use the same EK Dental Abutments, are manufactured from the same medical grade titanium materials and sterilized via gamma radiation. They only difference is the surface; SA is sand blasted and acid etched and NH which is SA + Dglucose + NaCI.
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized.
The EK Dental Implants and Abutments are available in various lengths and diameters; configurations are listed in the table below.
The provided document is a 510(k) premarket notification for dental implants and abutments. It focuses on demonstrating substantial equivalence to previously cleared devices, rather than proving the device meets specific acceptance criteria through a clinical or performance study with a test set, ground truth, or expert readers as typically seen for novel AI/ML medical devices.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not directly applicable to this type of submission.
Instead, the document demonstrates substantial equivalence by comparing the proposed EK Dental Implants and Abutments to predicate and reference devices across several key characteristics:
- Intended Use: The proposed devices have the same intended use as the predicate devices (supporting single or multiple-unit restorations in edentulous mandibles and maxillae, for delayed loading).
- Design/Structure: The proposed implants have an internal hex connection, are submerged fixtures, and have a tapered body shape, similar to the predicate devices. The abutments are also comparable in design to their reference devices.
- Material: The implants use Pure Titanium Grade 4 (ASTM F67) and Titanium alloy Ti-6Al-4V (ASTM F136), which are standard materials also used in the predicate devices. Abutments use similar materials (Ti-6Al-4V, Co-Cr-Mo Alloy, Gold alloy as per the reference devices).
- Surface Treatment: The implants employ SA (Sandblasted and Acid etched) and NH (SA + D-glucose + NaCl) surfaces, which are consistent with the predicate and reference devices.
- Sterilization: Implants are gamma irradiated, and abutments are provided non-sterile for steam sterilization by the user, matching the predicate/reference devices.
- Packaging: Similar packaging methods are used as the predicate devices.
- Performance Characteristics (Non-Clinical):
- Biocompatibility: Not re-tested, as the materials and manufacturing processes are the same as predicate/reference devices.
- Sterilization Validation: Not re-tested for implants (same process as predicate) or for abutments (provided non-sterile like reference devices, with user steam sterilization).
- Shelf Life: Not re-validated for implants (same as predicate's 8-year validated shelf life and packaging) or for abutments (non-sterile, non-mechanical, no stated shelf life, similar to reference devices).
- Surface Treatment Characterization: Not re-tested, as surfaces are manufactured using the same process and materials as predicate/reference devices.
- Fatigue Testing: Conducted in accordance with ISO 14801. The worst-case implant and abutment configurations withstood 5,000,000 cycles without failure at a substantially equivalent load to the primary predicate.
- Clinical Performance Testing: No clinical performance report(s) were submitted, indicating that substantial equivalence was demonstrated through non-clinical data and comparison to predicates.
In a 510(k) substantial equivalence submission for a traditional medical device like a dental implant, the "acceptance criteria" are effectively the demonstration of sufficient similarity in technological characteristics and performance (often non-clinical) to a legally marketed predicate device. The "study" proving this device meets the "acceptance criteria" is the comprehensive comparison outlined above, coupled with relevant non-clinical testing (like fatigue testing).
Therefore, I cannot populate the table or answer the specific questions in the format requested, as they pertain to a different type of validation study (e.g., for an AI/ML diagnostic algorithm, which would involve a test set, ground truth established by experts, and statistical performance metrics).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Hiossen, Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K203360
Trade/Device Name: EK Dental Implants and Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 6, 2021 Received: December 7, 2021
Dear Peter Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K203360 Device Name
EK Implants and Abutments System
Indications for Use (Describe)
The EK Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is indicated for delayed loading. Ultra wide versions are indicated for use in the molar region only.
The EK Dental Implants (Ø3.5mm) are made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The EK Dental Implants (Ø3.5mm) are indicated for use in mandibular and maxillary lateral and central incisor, 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.
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
Type of use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
[ Over-The-Counter Use (21 CFR 807 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image is a logo for Hiossen Implant. The logo has the letters "HI" in red and the word "OSSEN" in gray. The word "IMPLANT" is in gray and is located below the word "OSSEN".
5 Ben Fairless Drive www.hiossen.com
510(k) Summary
| 6.1 Submitter Information:Submitted by: | Hiossen, Inc.85 Ben Fairless DriveFairless Hills, PA 19030 |
|---|---|
| Contact Person:Telephone Number:Fax Number: | Peter Lee267-759-7031267-759-7031 |
| Date Prepared: | December 27, 2021 |
| 6.2 Device Name:• Proprietary Name:• Classification Name:• CFR Number:• Device Class:• Product Code:• Subsequent Product Code: | EK Implants and Abutments SystemEndosseous dental implant872.3640Class IIDZENHA |
6.3 Predicate Devices:
| Primary | 510(k) | Manufacturer(s) |
|---|---|---|
| Hiossen Implant System | K140934 | Hiossen, Inc. |
| Reference | 510(k) | Manufacturer |
|---|---|---|
| ETIII Bio-SA Fixture System | K151626 | Hiossen, Inc. |
| ETIII SA Fixture D3.2 | K153332 | Hiossen, Inc. |
| Osstem Abutment System | K182091 | Osstem Implant Co., Ltd. |
| Osstem Implant System - Abutment | K161689 | Osstem Implant Co., Ltd. |
| Hiossen Prosthetic System | K140507 | Osstem Implant Co., Ltd. |
| Prosthetic System | K110308 | Osstem Implant Co., Ltd. |
6.4 Description of Device:
The EK Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches, providing support to prosthetic devices to restore normal chewing functions. There are two types: SA and NH, both are bone level implants with the exact same internal hex, tapered body, use the same EK Dental Abutments, are manufactured from the same medical grade titanium materials and sterilized via gamma radiation. They only difference is the surface; SA is sand blasted and acid etched and NH which is SA + Dglucose + NaCI.
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized.
The EK Dental Implants and Abutments are available in various lengths and diameters; configurations are listed in the table below.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image is a logo for Hiossen Implant. The logo features the word "Hiossen" in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in smaller gray letters below "Hiossen". The logo is simple and modern, and it is likely used to promote the company's dental implant products.
| EK DENTAL IMPLANTS | Diameter (mm) | Length (mm) |
|---|---|---|
| EKIII SA Implants | 3.5 | 8.5, 10.0, 11.5, 13.0 |
| EKIII SA Implants | 4.0 ~ 5.5 | 7.0, 8.5, 10.0, 11.5, 13.0 |
| EKIII NH Implants | 3.5 | 8.5, 10.0, 11.5, 13.0 |
| EKIII NH Implants | 4.0 ~ 5.5 | 7.0, 8.5, 10.0, 11.5, 13.0 |
| EK DENTAL ABUTMENTS | Diameter (mm) | Length (mm) |
|---|---|---|
| EK Healing | 4.0 ~ 8.0 | 3.0 ~ 7.0 |
| EK Angled | 4.0 ~ 6.0 | 13.0, 15.0 |
| EK Freeform ST | 4.0 ~ 7.0 | 14.0, 15.0 |
| EK Goldcast | 4.0, 4.5 | 13.0 ~ 16.0 |
| EK Multi | 4.8 | 9.0 ~ 13.0 |
| EK Multi Angled | 4.8 | 6.0, 7.0, 8.0 |
| EK NP Cast | 4.0, 4.5 | 13.0 ~ 16.0 |
| EK Rigid | 4.0 ~ 7.0 | 4.0, 5.5, 7.0 |
| EK Stud | 3.5 | 9.0 ~ 15.0 |
| EK Temporary | 4.0, 4.5 | 13.0 ~ 16.0 |
| EK Transfer | 4.0 ~ 7.0 | 8.0 ~ 15.0 |
The EK Dental Implants and Abutments are similar to other commercially available products based on the intended use, the technology used, the material composition employed and performance characteristics.
6.5 Indication for Use:
The EK Dental Implants are indicated for use in partially or fully edentulous mandibles in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is indicated for delayed loading, Ultra wide versions are indicated for use in the molar region only.
The EK Dental Implants (Ø3.5mm) are made of titanium alloy (Ti 6AI 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The EK Dental Implants (Ø3.5mm) are indicated for use in mandibular and maxillary lateral and central incisor, 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.
The EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
6.6 Substantial Equivalence:
6.6.1 EK Dental Implants
The information and date provided in this submission established the EK Dental Implants are substantially equivalent to the primary predicate device, Hiossen Implant System (K140934).
| Device | Proposed DevicesEKIII SA Dental Implants | Primary PredicateDevicesHiossen Implant System | Reference DevicesETIII SA Fixture D3.2 |
|---|---|---|---|
| Manufacturer | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. |
| 510(K) No. | K203360 | K140934 | K153332 |
| Design | |||
| Intended use | The EK Dental Implantsare indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single ormultiple-unit restorationsincluding; cemented,screw or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is indicatedfor delayed loading. Ultra | The HIOSSEN ImplantSystem is indicated for usein partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading. ETIIISA Ultra-Wide Fixture isintended to be used in themolar region. | The ETIII SA FixtureSystem (Ø3.2mm) is madeof titanium alloy (Ti 6Al 4V)for Fixtures and SimpleMount and pure titaniumfor Cover Screw. The ETIIISA Fixture System(Ø3.2mm) is indicated foruse in mandibular andmaxillary lateral andcentral incisor, in supportof single or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading. |
| Image: EK Dental Implant | Image: HIOSSEN Implant | Image: ETIII SA Fixture | |
| Structure | • Internal Hex-connected• Submerged Fixture• Tapered body shape | • Internal Hex-connected• Submerged Fixture• Tapered body shape &Straight body shape | • Internal Hex-connected• Submerged Fixture• Straight body shape |
| Diameters | 3.5 ~5.5 | 3.5 ~ 7.0 | 3.2 |
| Lengths | 7.0 ~ 13.0 | 6.0 ~ 18.0 | 8.0 ~ 15.0 |
| Material | • Pure Titanium Grade 4(ASTM F67)• Titanium alloy Ti-6Al-4V(ASTM F136)* | • Pure Titanium Grade 4(ASTM F67) | • Titanium alloy Ti-6Al-4V(ASTM F136)* |
| Surface | • SA (Sandblasted andAcid etched) | • SA (Sandblasted andAcid etched) | • SA (Sandblasted andAcid etched) |
| Sterilization | Gamma Radiation | Gamma Radiation | Gamma Radiation |
| Packaging | • Secured in plasticampule• Housed in Tyvek-liddedblister tray• Placed in a tamper-evident outer package. | • Secured in plasticampule• Housed in Tyvek-liddedblister tray• Placed in a tamper-evident outer package. | • Secured in plasticampule• Housed in Tyvek-liddedblister tray• Placed in a tamper-evident outer package. |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image is a logo for Hiossen Implant. The logo features the word "Hiossen" in a stylized font, with the "H" in red and the rest of the word in gray. There is a red swoosh above the "H". Below the word "Hiossen" is the word "Implant" in smaller, gray letters.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is displayed in a stylized font, with "Hi" in red and "ossen" in gray. Below the word "Hiossen" is the word "Implant" in gray, with each letter separated by a space. The logo is simple and modern, and the use of color helps to draw the eye.
*3.5 diameter implant only
| Proposed Device | Primary PredicateDevices | Reference Devices | |
|---|---|---|---|
| Device | |||
| EKIII NH Dental Implants | EIII Bio-SA FixtureSystem | ETIII SA Fixture D3.2 | |
| Manufacturer | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. |
| 510(K) No. | New device | K151626 | K153332 |
| Design | Image: EKIII NH Dental Implants | Image: Elll Bio-SA Fixture System | Image: ETIII SA Fixture D3.2 |
| Intended use | The EK Dental Implantsare indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single ormultiple-unit restorationsincluding; cemented,screw or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is indicatedfor delayed loading. Ultrawide versions areindicated for use in themolar region only.The EK Dental Implants(Ø3.5mm) are made of | The ETIII Bio-SA FixtureSystem is indicated for usein partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading. Ultrawide Fixture System isintended to be used in themolar region. | The ETIII SA FixtureSystem (Ø3.2mm) is madeof titanium alloy (Ti 6Al 4V)for Fixtures and SimpleMount and pure titaniumfor Cover Screw. The ETIIISA Fixture System(Ø3.2mm) is indicated foruse in mandibular andmaxillary lateral andcenteral incisor, in supportof single or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intended |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in smaller gray letters below the word "Hiossen". The logo is simple and modern, and it is likely used to represent a company that manufactures or sells dental implants.
| for Fixtures and SimpleMount and pure titaniumfor Cover Screw. The EKDental Implants (Ø3.5mm)are indicated for use inmandibular and maxillarylateral and central incisor,in support of single ormultiple-unit restorationsincluding; cementedretained, screw retained,or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading.The EK Dental Abutmentsare indicated for use withEK Dental Implants toprovide support toprosthetic restoration suchas crowns, bridges andoverdentures in partially orfully edentulous patients. | |||
|---|---|---|---|
| Structure | • Internal Hex-connected• Submerged Fixture• Tapered body shape | • Internal Hex-connected• Submerged Fixture• Tapered body shape | • Internal Hex-connected• Submerged Fixture• Straight body shape |
| Diameters | 3.5 ~ 5.5 | 3.5 ~ 7.0 | 3.2 |
| Lengths | 7.0 ~ 13.0 | 6.0 ~ 15.0 | 8.0 ~ 15.0 |
| Material | • Pure Titanium Grade 4(ASTM F67)• Titanium alloy Ti-6Al-4V(ASTM F136)* | • Pure Titanium Grade 4(ASTM F67) | • Titanium alloy Ti-6Al-4V(ASTM F136)* |
| Surface | • NH (SA + D-glucose +NaCl) | • NH (SA + D-glucose +NaCl) | • NH (SA + D-glucose +NaCl)** |
| Sterilization | Gamma Radiation• Secured in plasticampule | Gamma Radiation• Secured in plasticampule | Gamma Radiation• Secured in plasticampule |
| Packaging | • Housed in Tyvek-liddedblister tray• Placed in a tamper-evident outer package | • Housed in Tyvek-liddedblister tray• Placed in a tamper-evident outer package | • Housed in Tyvek-liddedblister tray• Placed in a tamper-evident outer package |
- 3.5 diameter implant only
** NH version was adopted via internal documentation (letter to file).
| Device | Proposed DeviceEK Healing Abutment | Reference DevicesHiossen Healing Abutment |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Hiossen, Inc. |
| 510(K) No. | New device | K140934 |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the word "Hiossen" in a stylized font, with the "H" in red and the rest of the word in gray. The word "Implant" is written in smaller gray letters below the word "Hiossen". There is a registered trademark symbol next to the word "Hiossen".
| Design | Image: Dental implant | Image: Dental implant |
|---|---|---|
| Intended use | Used to make a natural soft tissue shapebefore setting up prosthetics andremoving cover screw afterosseointegration. | Used to make a natural soft tissue shapebefore setting up prosthetics andremoving cover screw afterosseointegration. |
| Diameters | 4.0 ~ 8.0 | 4.0 ~ 8.0 |
| Lengths | 3.0 ~ 7.0 | 3.0 ~ 7.0 |
| Material | • Pure Titanium Grade 4 (ASTM F67) | • Pure Titanium Grade 4 (ASTM F67) |
| Surface | • Machine surface | • Machine surface |
| Sterilization | • Gamma Radiation | • Gamma Radiation |
| Packaging | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage |
6.6.2 EK Dental Abutments
The information and date provided in this submission established the EK Dental Implants are substantially equivalent to the reference devices listed below.
| Device | Proposed DeviceEK Dental Abutments | Reference DevicesOsstem Abutment System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K182091 |
| Intended use | The EK Dental Abutments are indicatedfor use with EK Dental Implants toprovide support to prosthetic restorationsuch as crowns, bridges andoverdentures in partially or fullyedentulous patients. | The Osstem Abutments System areindicated for use with Hiossen Implantsto provide support to prostheticrestoration such as crowns, bridges andoverdentures in partially or fullyedentulous patients. |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6AI-4V (ASTM F136) | • Titanium alloy Ti-6AI-4V (ASTM F136) |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | • Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. |
| ANGLEDDesign | Image: Angled Design | Image: Angled Design |
| Diameters(mm) | 4.0 ~ 6.0 | 4.0 ~ 6.0 |
| Heights(mm) | 8.0 | 8.0 |
| Angulation | 17° | 17° |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the word "Hiossen" in a stylized font, with the "H" and part of the curve above the "i" in red, and the rest of the word in gray. Below the word "Hiossen" is the word "IMPLANT" in a smaller, sans-serif font, also in gray. The logo is simple and modern, and the use of red and gray gives it a professional look.
| MULTIANGLEDDesign | Image: Multi Angled Design 1 | Image: Multi Angled Design 2 | |
|---|---|---|---|
| Diameters(mm) | 4.8 | 4.8 | |
| G/H(mm) | 2.5 ~ 5.0 | 2.5 ~ 5.0 | |
| Angulation | 17° | 17°, 30° | |
| STUD Design | Image: STUD Design 1 | Image: STUD Design 2 | |
| Diameters(mm) | 3.5 | 3.5 | |
| G/H(mm) | 1.0 ~ 6.0 | 1.0 ~ 6.0 | |
| TEMPORARYDesign | Image: TEMPORARY Design 1 | Image: TEMPORARY Design 2 | |
| Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 | |
| Height(mm) | 10 | 10 | |
| TRANSFERDesign | Image: TRANSFER Design 1 | Image: TRANSFER Design 2 | |
| Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 | |
| Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |
| Device | Proposed DeviceEK Dental Abutments | Reference DevicesOsstem Implant System - Abutment |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K161689 |
| Intended use | The EK Dental Abutments are indicatedfor use with EK Dental Implants toprovide support to prosthetic restorationsuch as crowns, bridges andoverdentures in partially or fullyedentulous patients. | The Osstem Implant System - Abutmentsare indicated for use with HiossenImplants to provide support to prostheticrestoration such as crowns, bridges andoverdentures in partially or fullyedentulous patients. |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6AI-4V (ASTM F 136) | • Titanium alloy Ti-6AI-4V (ASTM F 136) |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Secured in plastic ampule | • Secured in plastic ampule |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the word "Hiossen" in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in smaller gray letters below the word "Hiossen". There is a registered trademark symbol next to the word "Hiossen".
| • Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | • Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | |
|---|---|---|
| FREEFORMST Design | Image: FREEFORM ST Design | Image: FREEFORM ST Design |
| Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 |
| G/H(mm) | 1.5, 3.0 | 1.5, 3.0 |
| MULTI Design | Image: MULTI Design | Image: MULTI Design |
| Diameters(mm) | 4.8 | 4.8 |
| G/H(mm) | 1.0 ~ 5.0 | 1.0 ~ 5.0 |
| RIGID Design | Image: RIGID Design | Image: RIGID Design |
| Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 |
| Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |
| Device | Proposed DeviceEK Dental Abutments | Reference DevicesHiossen Prosthetic System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K140507 |
| Intended use | The EK Dental Abutments are indicatedfor use with EK Dental Implants toprovide support to prosthetic restorationsuch as crowns, bridges andoverdentures in partially or fullyedentulous patients. | The Hiossen Prosthetic System areindicated for use with Hiossen Implantsto provide support to prostheticrestoration such as crowns, bridges andoverdentures in partially or fullyedentulous patients. |
| Material | • Co-Cr-Mo Alloy | • Co-Cr-Mo Alloy |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. |
| NP CASTDesign | Image: EK Dental Abutments | Image: Hiossen Prosthetic System |
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a stylized font, with the "H" and the curved line above it in red, and the rest of the word in gray. Below the word "Hiossen" is the word "IMPLANT" in smaller, gray letters. The logo is simple and modern, and it is likely used to represent a company that specializes in dental implants.
| Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 |
|---|---|---|
| Height(mm) | 10 | 10 |
| Design parameters | • Height: minimum 4.0mmm above margin• Wall thickness: 0.7mm and greater• Angulation: maximum of 30 degrees | • Height: minimum 4.0mmm above margin• Wall thickness: 0.7mm and greater• Angulation: maximum of 30 degrees |
| Device | Proposed DeviceEK Dental Abutments | Reference DevicesProsthetic System |
|---|---|---|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K110308 |
| Intended use | The EK Dental Abutments are indicatedfor use with EK Dental Implants toprovide support to prosthetic restorationsuch as crowns, bridges andoverdentures in partially or fullyedentulous patients. | The Prosthetic System are indicated foruse with Hiossen Implants to providesupport to prosthetic restoration such ascrowns, bridges and overdentures inpartially or fully edentulous patients. |
| Material | • Gold alloy | • Gold alloy |
| Sterilization | • Delivered non-sterilized• Steam sterilized by user | • Delivered non-sterilized• Steam sterilized by user |
| Packaging | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. | • Secured in plastic ampule• Housed in Tyvek-lidded blister tray• Placed in a tamper-evident outerpackage. |
| GOLD CASTDesign | ||
| Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 |
| Height(mm) | 10 | 10 |
| Designparameters | • Height: minimum 4.0mmm abovemargin• Wall thickness: 0.7mm and greater | • Height: minimum 4.0mmm abovemargin• Wall thickness: 0.7mm and greater |
| • Angulation: maximum of 30 degrees | • Angulation: maximum of 30 degrees |
6.7 Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following:
Biocompatibility Testing
The EK Dental Implants and Abutments are manufactured using the same manufacturing process and same well known and well established material as the predicate and reference devices, therefore we reason it was not necessary to re-test biocompatibility in order to support the biological safety of the EK Dental Implant and Abutments.
Sterilization Validation
The EK Dental Implants and healing abutments are gamma irradiated under the same conditions and process as the predicate device, the Hiossen Implant System (K140934) and validated following ISO 11137 [2006] Sterilization of health care products - Requirements for Validation and Routine control - Radiation Sterilization guidelines, therefore we reason it was not necessary to re-test validation in order to support
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the letters "HI" in red, with a red swoosh above the letters. The word "OSSEN" is in gray, and the word "IMPLANT" is in gray below the word "OSSEN".
iossen.com
the sterilization validity of the EK Dental Implants & healing abutments and includes acceptance of prior LAL endotoxin testing information from prior clearance.
EK Dental Abutments are provided non-sterile and can be moist heat sterilized as the reference devices, K182091. K161689. K140507 and K110308 which was validated following ISO 17665-1 (2006) Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, therefore we reason it was not necessary to re-test validation in order to support sterilization validity of the EK Dental Abutments.
Shelf Life
The EK Dental Implants shelf life are identical to the predicate device HIOSSEN Implant System (K140934) which has been validated for eight (8) years following ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. The EK Dental Implants utilizes the exact same packaging materials & methods and is a medical grade titanium, nonmechanical, non-active device, therefore, degradation in performance characteristics is not likely over the established shelf life period. Therefore, no shelf-life re-validation or accelerated aging re-testing was performed.
EK Dental Abutments like the predicate listed in this submission do not have a stated shelf life. The proposed devices are non-sterile and use the same exact packaging materials, manufactured from medical grade titanium alloy which are nonmechanical, non-active materials therefore, degradation in performance characteristics is not likely.
Surface Treatment Characterization Testing
The EK Dental Implants surfaces are manufactured using the same manufacturing process, material and is its surface is SA & NH treated just as the predicate device, the Hiossen Implant System (K140934) & ETIII SA Fixture D3.2 and coated SA treated ETIII Bio-SA Fixture System (K151626), therefore no additional surface characterization testing was necessary to support the equivalency of the EK Dental Implants.
The EK Dental Abutment surfaces are manufactured using the same manufacturing process, material and surface finishing as the predicate devices listed in this submission. No additional surface characterization testing was necessary to support the equivalency of the EK Dental Abutments.
Fatique Testing
Mechanical testing of EK Dental Implants and Abutments in accordance to ISO 14801 Dentistry - Fatique Test for Endosseous Dental Implants was conducted. The worst case implant and titanium, gold alloy and Co-Cr alloy abutments chosen for the tests were the smallest diameter implant loaded with abutments with the greatest angulation. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the primary predicate.
6.8 Clinical Performance Testing
No clinical performance report(s) is being submitted.
6.9 Conclusion
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 since the EK Dental Implant has the intended use, structure, material, surface, sterilization and packaging as the predicate device, Hiossen Implant System (K140934) and EK Dental Abutments are substantially equivalent. The propose devices do not pose any new or increased risk as compared to both the legally marketed predicate and reference devices.
§ 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.