(228 days)
No
The document describes a physical dental implant and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a dental implant intended to provide structural support for prosthetic devices to restore chewing functions, not to treat or cure a disease or condition.
No
The device is a dental implant intended for surgical placement to support prosthetic devices, not to diagnose a condition.
No
The device description explicitly states it is a surgically placed implant made of titanium alloy, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device description: The text clearly describes the EK Dental Implants as devices that are "surgically placed in the bone of the upper or lower jaw arches, providing support to prosthetic devices to restore normal chewing functions."
- Intended Use: The intended use is for supporting dental restorations in the mouth, not for analyzing biological specimens.
The device is a surgically implanted medical device, not an in vitro diagnostic device.
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 & Ø3.3mm) 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 & Ø3.3mm) are indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
Product codes
DZE
Device Description
The EK D3.3 and Ultra Wide 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 components and prosthetic parts, 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 is sand blasted and acid etched plus treated with a layer of low crystalline HA and super hydrophilic coating.
The EK D3.3 and Ultra Wide Dental Implants are available in various lengths and diameters; configurations are listed in the table below.
| EK DENTAL IMPLANTS | Diameter (mm) | Length (mm) |
|---|---|---|
| EKIII SA D3.3 Implants | 3.3 | 8.7, 10.2, 11.7, 13.2 |
| EKIII SA Ultra Wide Implants | 5.92 | 11.2, 12.7 |
| 5.95 | 6.4, 9.7 | |
| 6.0 | 7.2, 8.2 | |
| 6.8 | 6.4, 7.2, 8.2, 9.7, 11.2, 12.7 |
| EKIII NH D3.3 Implants | 3.3 | 8.7, 10.2, 11.7, 13.2 |
|---|---|---|
| EKIII NH Ultra Wide Implants | 5.92 | 11.2, 12.7 |
| 5.95 | 6.4, 9.7 | |
| 6.0 | 7.2, 8.2 | |
| 6.8 | 6.4, 7.2, 8.2, 9.7, 11.2, 12.7 |
The EK D3.3 and Ultra Wide Dental Implants are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
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 Performance Data
Biocompatibility Testing: The device is manufactured using the same manufacturing process and same well known and well-established material as the predicate devices, therefore, it was not necessary to re-test biocompatibility.
Sterilization Validation: The device is gamma irradiated under the same conditions and process as the predicate devices, and validated following ISO 11137 [2006], therefore it was not necessary to re-test validation.
Shelf Life: The device shelf life is identical to the predicate device EK SA Dental Implants (K203360), HIOSSEN Implant System (K140934) & ETIII SA Fixture D3.2 which has been validated for eight (8) years and EK NH Dental Implants (K203360), ETIII Bio-SA Fixture System (K151626) which has been validated for five (5) years following ISO 11607-1. No shelf-life re-validation or accelerated aging re-testing was performed.
Surface Treatment Characterization Testing: The device surfaces are manufactured using the same manufacturing process, material and its surface is SA treated type just as the predicate device EK SA Dental Implants (K203360), Hiossen Implant System (K140934) & ETIII SA Fixture D3.2 and NH treated type just as the predicate device EK NH Dental Implants (K203360) & ETIII Bio-SA Fixture System (K151626). No additional character testing was necessary.
Fatigue Testing: The device is manufactured using the same manufacturing process, material and same design, as the predicate EK Dental Implants (K203360). Fatigue testing performed in accordance with ISO 14801. The data provided in the submission demonstrates substantial equivalence.
MR conditional: Non-clinical worst-case MRI review was performed to evaluate the devices in the MRI environment using scientific rationale and published literature, based on the entire system including all variations (all compatible implantbodied, dental abutments and, fixation screws) and material composition. Rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Clinical Performance Testing: No clinical performance report(s) is being submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
September 12, 2024
Hiossen, Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K240232
Trade/Device Name: EK D3.3 and Ultra Wide Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: January 26, 2024 Received: August 13, 2024
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about mediation-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 -S
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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
EK D3.3 and Ultra Wide Dental Implants
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 & Ø3.3mm) 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 & Ø3.3mm) are indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Image /page/4/Picture/0 description: The image is a logo for Hiossen Implant. The word "Hiossen" is written in a combination of red and gray letters. The word "Implant" is written in gray letters below the word "Hiossen."
85 Ben Fairless Drive A 19030 888-768-0001 www.hiossen.com
DZE
510(k) Summary
| Submitter Information: | K24023 |
|---|---|
| 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: | September 12, 2024 |
| Device Name: | |
| • Proprietary Name: | EK D3.3 and Ultra Wide Dental Implants |
| • Classification Name: | Endosseous dental implant |
| • CFR Number: | 872.3640 |
| • Device Class: | Class II |
Predicate Devices:
• Product Code:
| Primary | 510(k) | Manufacturer(s) |
|---|---|---|
| EK Dental Implants and Abutments System | K203360 | Hiossen, Inc. |
| Reference | 510(k) | Manufacturer(s) |
| Hiossen Implant System* | K140934 | Hiossen, Inc. |
| ETIII Bio-SA Fixture System | K151626 | Hiossen, Inc. |
| ETIII SA Fixture D3.2 | K153332 | Hiossen, Inc. |
Description of Device:
The EK D3.3 and Ultra Wide 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 components and prosthetic parts, 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 is sand blasted and acid etched plus treated with a layer of low crystalline HA and super hydrophilic coating.
The EK D3.3 and Ultra Wide Dental Implants are available in various lengths and diameters; configurations are listed in the table below.
| EK DENTAL IMPLANTS | Diameter (mm) | Length (mm) |
|---|---|---|
| EKIII SA D3.3 Implants | 3.3 | 8.7, 10.2, 11.7, 13.2 |
| EKIII SA Ultra Wide Implants | 5.92 | 11.2, 12.7 |
| 5.95 | 6.4, 9.7 | |
| 6.0 | 7.2, 8.2 | |
| 6.8 | 6.4, 7.2, 8.2, 9.7, 11.2, 12.7 |
5
Image /page/5/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 gray 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.
85 Ben Fairless Drive
Fairless Hills, PA 19030
888-768-0001
www.hiossen.com
| EKIII NH D3.3 Implants | 3.3 | 8.7, 10.2, 11.7, 13.2 |
|---|---|---|
| EKIII NH Ultra Wide Implants | 5.92 | 11.2, 12.7 |
| 5.95 | 6.4, 9.7 | |
| 6.0 | 7.2, 8.2 | |
| 6.8 | 6.4, 7.2, 8.2, 9.7, 11.2, 12.7 |
The EK D3.3 and Ultra Wide Dental Implants are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
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 & Ø3.3mm) 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, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
Substantial Equivalence:
The EK D3.3 and Ultra Wide Dental Implants
The information and data provided in this submission established the EK D3.3 and Ultra Wide Dental Implants are substantially equivalent to the primary predicate devices, EK Dental Implant (K203360).
6
Image /page/6/Picture/0 description: The image is a logo for Hiossen Implant. The word "Hiossen" is written in a combination of red and gray letters. Below the word "Hiossen" is the word "Implant" written in gray letters.
| Device | Proposed Devices
EK SA D3.3 and
Ultra Wide Dental
Implants | Predicate Devices
EKIII SA Dental
Implants | Reference Devices
Hiossen Implant
System | Reference Devices
ETIII SA Fixture D3.2 | Similarities/
Differences |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. | |
| 510(K) No. | New device | K203360 | K140934 | K153332 | |
| Design | Image: Proposed Devices EK SA D3.3 and Ultra Wide Dental Implants | Image: Predicate Devices EKIII SA Dental Implants | Image: Reference Devices Hiossen Implant System | Image: Reference Devices ETIII SA Fixture D3.2 | Similar
Difference: Size addition. Does
not pose any new or increased risk. |
| 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 & Ø3.3mm)
are made of titanium
alloy (Ti 6Al 4V) for
Fixtures and Simple
Mount and pure | 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 | 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. | Similar
Difference: To
specify that the
restriction of the
3.3mm diameter
implant bodies to
the lateral
incisors which is
covered in the
indications of the
K153332
submission |
| | titanium for Cover
Screw. The EK Dental
Implants (Ø3.5mm &
Ø3.3mm) 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. | 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
• Tapered body shape
& Straight body shape | • Internal Hex-
connected
• Submerged Fixture
• Straight body shape | Similar
Difference: Size
addition. Does
not pose any new
or increased risk. |
| Diameters(mm) | 3.3, 5.92, 5.95, 6.0,
6.80 | 3.5 ~ 5.5 | 3.5 ~ 7.0 | 3.2 | Equivalent |
| Lengths(mm) | 6.4, 7.2, 8.2, 8.7, 9.7,
10.2, 11.2, 11.7, 12.7,
13.2 | 7.0 ~ 13.0 | 6.0 ~ 18.0 | 8.0 ~ 15.0 | Equivalent |
| Diameter x
Length(mm) | 3.3 x 8.7, 10.2, 11.7,
13.2
5.92 x 11.2, 12.7
5.95 x 6.4, 9.7
6.0 x 7.2, 9.7
6.8 x 6.4, 7.2, 8.2, 9.7,
11.2, 12.7 | 3.5 x 8.0 ~ 13.0
4.0 ~ 5.5 x 7.0 ~ 13.0 | 3.5 x 8.0 ~ 18.0
4.0 ~ 4.5 x 7.0 ~ 18.0
5.0 x 6.0 ~ 18.0
7.0 ~ 6.0 x 6.0 ~ 13.0 | 3.2 x 8.0 ~ 15.0 | Similar
Difference: Size
addition. Does
not pose any new
or increased risk. |
| 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) | • Pure Titanium Grade
4 (ASTM F67) | • Titanium alloy Ti-6Al-
4V (ASTM F136)* | Equivalent |
| Surface | • SA (Sandblasted and
Acid etched) | • SA (Sandblasted and
Acid etched) | • SA (Sandblasted and
Acid etched) | • SA (Sandblasted and
Acid etched) | Equivalent |
| Sterilization | Gamma Radiation | Gamma Radiation | Gamma Radiation | Gamma Radiation | Equivalent |
| 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. | • Secured in plastic
ampule
• Housed in Tyvek-
lidded blister tray
• Placed in a tamper-
evident outer package. | Equivalent |
| Shelf life | 8 years | 8 years | 8 years | 8 years | Equivalent |
7
Image /page/7/Picture/0 description: The image is a 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". The logo is simple and modern.
8
Image /page/8/Picture/0 description: The image shows the logo for Hiossen Implant. The logo is composed of the letters "HI" in red, followed by "OSSEN" in gray. A registered trademark symbol is next to the word "OSSEN". Below the word "OSSEN" is the word "IMPLANT" in gray.
*3.3 diameter implant only
| Device | Proposed Device
EK NH D3.3 and
Ultra Wide Dental
Implants | Proposed Device
EKIII NH Dental
Implants | Predicate Devices
EIII Bio-SA Fixture
System | Predicate Devices
ETIII SA Fixture D3.2 | Similarities/
Differences |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. | Hiossen, Inc. | |
| 510(K) No. | New device | K203360 | K151626 | K153332 | |
| Design | | | | | Similar
Difference: Size
addition. Does
not pose any new
or increased risk. |
| | | | | | |
| 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 & Ø3.3mm)
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 &
Ø3.3mm) are indicated
for use in mandibular
and maxillary lateral
and central incisor, in | 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 | 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 for delayed
loading. | Similar
Difference: To
specify that the
restriction of the
3.3mm diameter
implant bodies to
the lateral
incisors which is
covered in the
indications of the
K153332
submission |
| | 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. | 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 | • Internal Hex-
connected | • Internal Hex-
connected | • Internal Hex-
connected | Similar |
| | • Submerged Fixture | • Submerged Fixture | • Submerged Fixture | • Submerged Fixture | Difference: Size |
| | • Tapered body shape | • Tapered body shape | • Tapered body shape | • Straight body shape | addition. Does |
| | | | | | not pose any new |
| | | | | | or increased risk. |
| Diameters(mm) | 3.3, 5.92, 5.95, 6.0,
6.80 | 3.5 ~ 5.5 | 3.5 ~ 7.0 | 3.2 | Equivalent |
| Lengths(mm) | 6.4, 7.2, 8.2, 8.7, 9.7,
10.2, 11.2, 11.7, 12.7,
13.2 | 7.0 ~ 13.0 | 6.0 ~ 15.0 | 8.0 ~ 15.0 | Equivalent |
| Diameter x
Length(mm) | 3.3 x 8.7, 10.2, 11.7,
13.2
5.92 x 11.2, 12.7
5.95 x 6.4, 9.7 | 3.5 x 8.0 ~ 13.0
4.0 ~ 5.5 x 7.0 ~ 13.0 | 3.5 x 8.0 ~ 18.0
4.0 ~ 4.5 x 7.0 ~ 18.0
5.0 x 6.0 ~ 18.0
7.0 ~ 6.0 x 6.0 ~ 13.0 | 3.2 x 8.0 ~ 15.0 | Similar
Difference: Size
addition. Does |
| | 6.0 x 7.2, 9.7
6.8 x 6.4, 7.2, 8.2, 9.7,
11.2, 12.7 | | | | not pose any new
or increased risk. |
| 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) | • Pure Titanium Grade
4 (ASTM F67) | • Titanium alloy Ti-6Al-
4V (ASTM F136)* | Equivalent |
| Surface | • NH (Sand blasted and
Acid etched + nano
calcium phosphate + D-
glucose + NaCl) | • NH (Sand blasted and
Acid etched + nano
calcium phosphate + D-
glucose + NaCl) | • NH (Sand blasted and
Acid etched + nano
calcium phosphate + D-
glucose + NaCl) | • SA (Sand blasted and
acid etched) | Equivalent |
| Sterilization | Gamma Radiation | Gamma Radiation | Gamma Radiation | Gamma Radiation | Equivalent |
| 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. | • Secured in plastic
ampule
• Housed in Tyvek-
lidded blister tray
• Placed in a tamper-
evident outer package. | Equivalent |
| Shelf life | 5 years | 5 years | 5 years | 5 years | Equivalent |
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Image /page/9/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.
EK D3.3 and Ultra Wide IMPLANTS TRADITIONAL 510(k) Confidential
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Image /page/10/Picture/0 description: The image shows the Hiossen Implant logo. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the word in gray. Below the word "Hiossen" is the word "IMPLANT" in gray.
EK D3.3 and Ultra Wide IMPLANTS TRADITIONAL 510(k) Confidential
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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 part of the "i" in red, and the rest of the word in gray. A registered trademark symbol is next to the word. Below the word "Hiossen" is the word "IMPLANT" in gray.
*3.3 diameter implant only
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Image /page/12/Picture/0 description: The image is a logo for Hiossen Implant. The word "Hiossen" is written in a combination of red and gray letters. The word "Implant" is written in gray letters below the word "Hiossen". The logo is simple and modern.
Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:
Biocompatibility Testing
The EK D3.3 and Ultra Wide Dental Implants are manufactured using the same manufacturing process and same well known and well-established material as the predicate devices; therefore, we reason it was not necessary to re-test biocompatibility in order to support the biological safety of the EK D3.3 and Ultra Wide Dental Implants as well as leveraging K203360's biocompatibility assessment. Furthermore, as described in International Standard Organization (ISO) standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing when a new material is used that has not been identified in a primary predicate device. The proposed devices are manufactured from standard raw material that are used in the primary predicate devices and other currently marketed dental implant system. Therefore, no additional biocompatibility testing is required to establish substantial equivalence.
Sterilization Validation
The EK D3.3 and Ultra Wide Dental Implants (manufactured using the same manufacturing process, material and utilizes the same sterilize barrier system) are gamma irradiated under the same conditions and process as the predicate devices, the EK Dental Implants (K203360), Hiossen Implant System (K140934), ETIII Bio-SA Fixture System (K151626) & ETIII SA Fixture D3.2 (K153332) 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 the sterilization validity of the EK D3.3 and Ultra Wide Dental Implants.
Shelf Life
The EK D3.3 and Ultra Wide Dental Implants shelf life are identical to the predicate device EK SA Dental lmplants (K203360), HIOSSEN Implant System (K140934) & ETIII SA Fixture D3.2 which has been validated for eight (8) years and EK NH Dental Implants (K203360), ETIII Bio-SA Fixture System (K151626) which has been validated for five (5) years following ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. The EK D3.3 and Ultra Wide Dental Implants utilizes the exact same packaging materials & methods and is a medical grade titanium, non-mechanical, 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.
Surface Treatment Characterization Testing
The EK D3.3 and Ultra Wide Dental Implants surfaces are manufactured using the same manufacturing process, material and its surface is SA treated type just as the predicate device, the EK SA Dental Implants (K203360), Hiossen Implant System (K140934) & ETIII SA Fixture D3.2 and NH treated type just as the predicate device EK NH Dental Implants (K203360) & ETIII Bio-SA Fixture System (K151626). The surface area analysis and bone-in-contact testing for the wide diameter implants are referenced from K140934 and state no changes in design was made that might affect surface area and bone-in-contact analysis, therefore no additional character testing was necessary to support the EK D3.3 and Ultra Wide Dental Implants.
Fatigue Testing
The EK D3.3 and Ultra Wide Dental Implants are manufactured using the same manufacturing process, material and same design, as the predicate EK Dental Implants (K203360). Fatigue testing performed in accordance with ISO 14801 Dentistry – Fatigue Test for Endosseous Dental Implants. The data provided in the submission demonstrates substantial equivalence.
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Image /page/13/Picture/0 description: The image is a 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". The logo is simple and modern.
5 Ben Fairless Drive airless Hills PA 19030 www.hiossen.com
MR conditional
Non-clinical worst-case MRI review was performed to evaluate Hiossen, Inc. EK D3.3 and Ultra Wide Dental Implants in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0.. Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. Rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Clinical Performance Testing
No clinical performance report(s) is being submitted.
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 D3.3 and Ultra Wide Dental Implants has the same design, intended use, structure, diameters, lengths, material, surface, sterilization and packaging as the predicate devices, EK Dental Implants (K203360), Hiossen Implant System (K140934), ETIII Bio-SA Fixture System (K151626) & ETIII SA Fixture D3.2. The propose devices do not pose any new or increased risk as compared to both the legally marketed predicate and reference devices.