(417 days)
No
The summary describes a physical dental implant and abutment system made of titanium, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as dental implants and abutments used to support prosthetic restorations for chewing functions, which are structural and restorative rather than therapeutic.
No
Explanation: The device, EK Dental Implants, is described as being used for supporting single or multiple-unit restorations by being surgically placed in the bone. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly states that the device is a physical dental implant made of titanium alloy and pure titanium, intended for surgical placement. It also describes physical abutments.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The EK Dental Implants and Abutments are described as surgically placed devices intended to support prosthetic devices for restoring chewing functions. They are physical implants and components, not tests performed on biological samples.
- Intended Use: The intended use clearly states their purpose is to support dental restorations in the mouth, not to diagnose or monitor a medical condition through analysis of biological samples.
The device is a medical device, specifically a dental implant system, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae, mandibular and maxillary lateral and central incisor, molar region
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)
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 it was not necessary to re-test biocompatibility.
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]. 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).
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. EK Dental Abutments like the predicate listed in this submission do not have a stated shelf life.
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. 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.
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.
No clinical performance report(s) is being submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K151626, K153332, K182091, K161689, K140507, K110308
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
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FORM FDA 3881 (7/17)
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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 Drive
Fairless Hills, PA 19030 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Contact Person:
Telephone Number:
Fax Number: | Peter Lee
267-759-7031
267-759-7031 |
| 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 System
Endosseous dental implant
872.3640
Class II
DZE
NHA |
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 Devices
EKIII SA Dental Implants | Primary Predicate
Devices
Hiossen Implant System | Reference Devices
ETIII SA Fixture D3.2 |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. |
| 510(K) No. | K203360 | K140934 | K153332 |
| Design | | | |
| Intended use | 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
| 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 ETIII SA Fixture
System (Ø3.2mm) is made
of titanium alloy (Ti 6Al 4V)
for Fixtures and Simple
Mount and pure titanium
for Cover Screw. The ETIII
SA Fixture System
(Ø3.2mm) is 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. |
| | 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 and
Acid etched) | • SA (Sandblasted and
Acid etched) | • SA (Sandblasted and
Acid etched) |
| Sterilization | Gamma Radiation | Gamma Radiation | Gamma Radiation |
| Packaging | • Secured in plastic
ampule
• Housed in Tyvek-lidded
blister tray
• Placed in a tamper-
evident outer package. | • Secured in plastic
ampule
• Housed in Tyvek-lidded
blister tray
• Placed in a tamper-
evident outer package. | • Secured in plastic
ampule
• Housed in Tyvek-lidded
blister 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 Predicate
Devices | Reference Devices |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | | | |
| | EKIII NH Dental Implants | EIII Bio-SA Fixture
System | 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 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 | The ETIII Bio-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. Ultra
wide Fixture System is
intended to be used in the
molar region. | The ETIII SA Fixture
System (Ø3.2mm) is made
of titanium alloy (Ti 6Al 4V)
for Fixtures and Simple
Mount and pure titanium
for Cover Screw. The ETIII
SA Fixture System
(Ø3.2mm) is indicated for
use in mandibular and
maxillary lateral and
centeral 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 |
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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 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. | | |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| 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 plastic
ampule | Gamma Radiation
• Secured in plastic
ampule | Gamma Radiation
• Secured in plastic
ampule |
| Packaging | • Housed in Tyvek-lidded
blister tray
• Placed in a tamper-
evident outer package | • Housed in Tyvek-lidded
blister tray
• Placed in a tamper-
evident outer package | • Housed in Tyvek-lidded
blister 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 Device
EK Healing Abutment | Reference Devices
Hiossen 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 shape | |
| before setting up prosthetics and | ||
| removing cover screw after | ||
| osseointegration. | Used to make a natural soft tissue shape | |
| before setting up prosthetics and | ||
| removing cover screw after | ||
| osseointegration. | ||
| 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 outer | ||
| package | • Secured in plastic ampule | |
| • Housed in Tyvek-lidded blister tray | ||
| • Placed in a tamper-evident outer | ||
| package |
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 Device
EK Dental Abutments | Reference Devices
Osstem Abutment System |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K182091 |
| Intended use | 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 Osstem Abutments System are
indicated for use with Hiossen Implants
to provide support to prosthetic
restoration such as crowns, bridges and
overdentures in partially or fully
edentulous 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 outer
package. | • Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. |
| ANGLED
Design | 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.
| MULTI
ANGLED
| Design | 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 | |
| TEMPORARY | |||
| Design | Image: TEMPORARY Design 1 | Image: TEMPORARY Design 2 | |
| Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 | |
| Height(mm) | 10 | 10 | |
| TRANSFER | |||
| Design | 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 Device
EK Dental Abutments | Reference Devices
Osstem Implant System - Abutment |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K161689 |
| Intended use | 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 Osstem Implant System - Abutments
are indicated for use with Hiossen
Implants to provide support to prosthetic
restoration such as crowns, bridges and
overdentures in partially or fully
edentulous 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 outer
package. | • Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. |
|-----------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| FREEFORM
ST 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 Device
EK Dental Abutments | Reference Devices
Hiossen Prosthetic System |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K140507 |
| Intended use | 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 Hiossen Prosthetic System are
indicated for use with Hiossen Implants
to provide support to prosthetic
restoration such as crowns, bridges and
overdentures in partially or fully
edentulous 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 outer
package. | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. |
| NP CAST
Design | 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 Device
EK Dental Abutments | Reference Devices
Prosthetic System |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K110308 |
| Intended use | 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 Prosthetic System are indicated for
use with Hiossen Implants to provide
support to prosthetic restoration such as
crowns, bridges and overdentures in
partially 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 outer
package. | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. |
| GOLD CAST
Design | | |
| 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 | • Height: minimum 4.0mmm above
margin
• 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.