(240 days)
No
The summary describes a digitally designed and manufactured dental abutment, but there is no mention of AI or ML in the device description, intended use, or performance studies. The design process is described as "digitally designed patient specific," which is common for CAD/CAM processes and does not inherently imply AI/ML.
No.
The device's intended use is to provide support for prosthetic dental restorations, which is a structural and restorative function, not a therapeutic one aimed at treating a disease or condition.
No
Explanation: The device is described as a support for prosthetic restorations for dental implants, and its function is to provide mechanical support rather than to diagnose medical conditions.
No
The device description explicitly states that the device is manufactured from titanium alloy and titanium alloy + zirconia, and involves physical components like a pre-manufactured titanium base and a CAD/CAM patient-matched mesostructure component. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic restorations in the mouth, connected to a dental implant. This is a mechanical function within the body.
- Device Description: The device is a physical abutment made of titanium and zirconia, designed to be surgically placed and support a dental prosthesis.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a structural component.
N/A
Intended Use / Indications for Use
EK DIGITAL ABUTMENTS are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
EK DIGITAL ABUTMENTS are digitally designed patient specific abutments manufactured from titanium Alloy (Ti-6AI-4V ELI) and titanium alloy + zirconia. The EK Hybrid abutments are a two-piece abutment consisting of a pre-manufactured titanium base (ASTM F136) and a CAD/CAM patient-matched mesostructure component (ISO 6872) and PANAVIA F 2.0 (K032455) cement is used to attach the two structures. They are intended only for use with HIOSSEN EK dental implants to provide support for customized prosthetic restorations. EK DIGITAL ABUTMENTS are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. Each EK DIGITAL ABUTMENT is individually prescribed by the clinician. The EK Digital Abutments are only compatible with EK Dental Implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 tests:
Biocompatibility Testing: The EK Digital Abutments are manufactured using the same manufacturing process and same well known and well-established material as the predicate device; therefore, it was not necessary to re-test biocompatibility.
Sterilization Validation: The EK Digital Abutment are manufactured by the predicate device manufacturing process, material and utilizes the same packing materials) are not sterilized like the predicate devices listed in this submission. Like the predicate devices the proposed can be moist heat sterilized and was validated following ISO 17665-1 [2006] Sterilization of health care products - 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 Digital Abutments.
Shelf Life: The EK Digital Abutment 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 non-mechanical, non-active materials therefore, degradation in performance characteristics is not likely.
Surface Treatment Characterization Testing: The EK Digital Abutment are manufactured by the predicate device manufacturer, with surfaces using the same manufacturing process, material and surface finishing as the predicate devices listed in this submission. No additional character testing was necessary to support the equivalency of the EK Digital Abutments.
Mechanical Properties: The EK Digital Abutment System Mechanical testing was conducted in accordance to ISO 14801 Dentistry - Fatique Test for Endosseous Dental Implants. The worst case implant and titanium 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.
Clinical Performance Testing: 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.
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
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
May 29, 2024
Re: K233389
Trade/Device Name: EK Digital Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 28, 2024 Received: May 28, 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.
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 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 -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
Image /page/3/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the letters "HI" in red, with a curved line above the "H". The rest of the word "OSSEN" is in gray, with a registered trademark symbol next to it. Below the word "OSSEN" is the word "IMPLANT" in gray.
Section 5 Indication for Use Statement - 1 PAGE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
EK Digital Abutments
Indications for Use (Describe)
EK DIGITAL ABUTMENTS are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
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Image /page/4/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a sans-serif font, with the "H" in red and the rest of the letters in gray. There is a red swoosh above the "H". Below the word "Hiossen" is the word "Implant" in a smaller, gray sans-serif font.
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: | May 29, 2024 |
| 6.2 Device Name:
• Proprietary Name:
• Classification Name:
• CFR Number:
• Device Class: | EK Digital Abutments
Implant, Endosseous, Root-form
872.3630
Class II |
NHA
6.3 Predicate Devices:
• Product Code:
| Primary | 510(k) | Manufacturer(s) |
|---|---|---|
| ET SMARTFIT ABUTMENT | K123627 | HIOSSEN, INC. |
| Reference | 510(k) | Manufacturer(s) |
| ET HYBRID ABUTMENT | K162390 | HIOSSEN, INC. |
| EK DENTAL IMPLANT SYSTEM | K203360 | HIOSSEN, INC. |
6.4 Description of Device:
EK DIGITAL ABUTMENTS are digitally designed patient specific abutments manufactured from titanium Alloy (Ti-6AI-4V ELI) and titanium alloy + zirconia. The EK Hybrid abutments are a two-piece abutment consisting of a pre-manufactured titanium base (ASTM F136) and a CAD/CAM patient-matched mesostructure component (ISO 6872) and PANAVIA F 2.0 (K032455) cement is used to attach the two structures. They are intended only for use with HIOSSEN EK dental implants to provide support for customized prosthetic restorations. EK DIGITAL ABUTMENTS are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. Each EK DIGITAL ABUTMENT is individually prescribed by the clinician.
The EK Digital Abutments are only compatible with EK Dental Implants
| Propriety Name | EK Implant System |
|---|---|
| 510(k) Number | K203360 |
| Implant Diameters | 3.5, 4.0, 4.5, 5.0, 5.5 |
| Connection Type | Internal connection |
| Implant - Abutment Connection Type | Hex or Non-Hex |
5
Image /page/5/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 letters in gray. The word "Implant" is written in smaller gray letters below the word "Hiossen". The logo is simple and modern.
The EK Digital Abutments are available in various lengths and diameters; configurations are listed in the table below.
Image /page/5/Figure/3 description: This image shows a diagram of a EK ONEFIT. There are labels A, B, C, and D indicating different measurements of the diagram. The diagram shows the shape of the EK ONEFIT.
| Code | A (mm) | B (mm) | C (mm) | D(°) | Connection |
|---|---|---|---|---|---|
| EKCMA01H | 4.0 | 0.5 ~ 12.0 | 4.0 ~ 15.5 | 0 ~ 10 | Hex |
| EKCMA01N | 2.6 | 0.5 ~ 12.0 | 4.0 ~ 15.5 | 0 ~ 10 | Non-hex |
| EKCMA12H | 4.0 | 0.5 ~ 12.0 | 4.0 ~ 15.5 | 10.1 ~ 20 | Hex |
| EKCMA12N | 2.6 | 0.5 ~ 12.0 | 4.0 ~ 15.5 | 10.1 ~ 20 | Non-hex |
| EKCMA23H | 4.0 | 0.5 ~ 12.0 | 4.0 ~ 15.5 | 20.1 ~ 30 | Hex |
| EKCMA23N | 2.6 | 0.5 ~ 12.0 | 4.0 ~ 15.5 | 20.1 ~ 30 | Non-hex |
Image /page/5/Figure/5 description: This image is a technical drawing of a nozzle. The drawing includes labels A, B, C, D, and F, which likely correspond to specific dimensions or features of the nozzle. The nozzle appears to be a conical shape with a threaded connection at one end.
| Code | A (mm) | B (mm) | C (mm) | D (mm) | F (°) | Connection |
|---|---|---|---|---|---|---|
| EKHZA4041CHT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4041CNT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4041HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4041NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0 ~ 30 | Non-hex |
| EKHZA4042CHT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4042CNT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4042HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4042NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4043CHT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4043CNT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4043HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4043NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4044CHT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4044CNT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4044HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4044NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4061HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
EK HYBRID
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Image /page/6/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the letters "HI" in red, with a curved line above the letters. The word "OSSEN" is in gray, with a registered trademark symbol next to it. Below the word "OSSEN" is the word "IMPLANT" in gray, with the letters spaced out.
| EKHZA4061NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0 ~ 30 | Non-hex |
|---|---|---|---|---|---|---|
| EKHZA4062HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4062NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4063HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4063NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4064HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4064NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4541CHT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4541CNT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0 ~ 30 | Non-hex |
| EKHZA4541HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4541NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0 ~ 30 | Non-hex |
| EKHZA4542CHT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4542CNT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4542HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4542NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4543CHT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4543CNT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4543HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0 ~ 30 | Hex |
| EKHZA4543NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4544CHT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4544CNT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0 ~ 30 | Non-hex |
| EKHZA4544HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0 ~ 30 | Hex |
| EKHZA4544NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4561HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4561NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4562HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4562NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4563HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4563NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Non-hex |
| EKHZA4564HT | 4.0 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0~30 | Hex |
| EKHZA4564NT | 2.6 | 0.8 ~ 3.8 | 1.9 ~ 4.9 | 4.0 ~ 15.0 | 0 ~ 30 | Non-hex |
EK Abutment Screw
Image /page/6/Picture/9 description: The image shows a technical drawing of a cylindrical object. The drawing includes three views of the object, labeled A, B, and C. View A shows a side view of the object, view B shows a cross-sectional side view, and view C shows an end view.
| Code | A (mm) | B (mm) | C(mm) |
|---|---|---|---|
| EKABSTEP | 2.12 | 8.7 | 1.20 |
The EK Digital Abutments are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
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Image /page/7/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. The word "IMPLANT" is written in smaller gray letters below the word "Hiossen". The logo is simple and modern.
6.5 Indication for Use:
EK DIGITAL ABUTMENTS are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
6.6 Substantial Equivalence:
6.6.1 EK Digital Abutments
The information and date provided in this submission established the EK Digital Abutment are substantially equivalent to the primary predicate devices listed below. The materials used, manufacturing process, design limitations are same except for the connection and compatible dental implant.
| Device | Proposed Device
EK Digtal Abutments | Primary Predicate Devices
ET Smartfit Abutment | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Hiossen, Inc. | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(K) No. | K233389 | K123627 | | | | | | | | | | | | | | | | | | | | | | | | |
| Intended use | EK DIGITAL ABUTMENTS are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. | ET SMARTfit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. | | | | | | | | | | | | | | | | | | | | | | | | |
| Sterilization | • Delivered non-sterilized
• Steam sterilized by user | • Delivered non-sterilized
• Steam sterilized by user | | | | | | | | | | | | | | | | | | | | | | | | |
| Packaging | • PT+PE Pouch | • PT+PE Pouch | | | | | | | | | | | | | | | | | | | | | | | | |
| EK ONEFIT | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Design | Image: EK Digital Abutments design | Image: ET Smartfit Abutment design | | | | | | | | | | | | | | | | | | | | | | | | |
| Surface | Machine surface | Machine surface | | | | | | | | | | | | | | | | | | | | | | | | |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) | | | | | | | | | | | | | | | | | | | | | | | | |
| Design
Limitations | Connection Non-hex Hex Diameter (D) 4.215 (mm) 4.715 (mm) Wall Thick. 0.350.55 (mm) 0.400.65 (mm) Post Height(H)* 415.5(mm) 415.5 (mm) Post Wall Thick(t) 0.72.7 (mm) 1.24.2 (mm) Post Diameter (d) 2.56.5 (mm) 3.09.0 (mm) Gingival Margin Height (G/H) 0.58.5 (mm) 0.58.5 (mm) Abutment Taper(A) 030(°) 030(°) *Post height is the height above any gingival collar height | | | | | | | | | | | | | | | | | | | | | | | | | • Height: minimum 4.0mm above margin
• Wall thickness: 0.7mm and greater
• Angulation: maximum of 30° |
| Device | Proposed Device
EK Digital Abutments | Secondary Predicate Devices
ET Hybrid |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Hiossen, Inc. |
| 510(K) No. | K233389 | K162390 |
| Intended use | EK DIGITAL ABUTMENTS are intended for
use with a dental implant to provide support
for prosthetic restorations such as crowns,
bridges, or overdentures. | ET Hybrid Abutment is intended for use
with a dental implant to provide
support for prosthetic restorations such as
crowns and bridges. |
| Sterilization | • Delivered non-sterilized
• Steam sterilized by user | • Delivered non-sterilized
• Steam sterilized by user |
| Packaging | • PT+PE Pouch | • PT+PE Pouch |
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Image /page/8/Picture/0 description: The image is a 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 "Hiossen". There is a registered trademark symbol next to the word "Hiossen".
85 Ben Fairless Drive
Fairless Hills, PA 19030
888-768-0001
www.hiossen.com
| EK HYBRID | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Design | ||||||||||||||||||||||||||||||
| Surface | Machine surface | Machine surface | ||||||||||||||||||||||||||||
| Material | • Titanium alloy Ti-6Al-4V (ASTM F 136) | |||||||||||||||||||||||||||||
| • Zirconium oxide | • Titanium alloy Ti-6Al-4V (ASTM F 136) | |||||||||||||||||||||||||||||
| • Zirconium oxide | ||||||||||||||||||||||||||||||
| Design | ||||||||||||||||||||||||||||||
| Limitations | Connection | |||||||||||||||||||||||||||||
| Non-hex Hex Diameter (D) 4.2 | ||||||||||||||||||||||||||||||
| Height (G/H) 0.8 | ||||||||||||||||||||||||||||||
| Margin Height (G/H) 1.9 |
6.7 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 Digital Abutment are manufactured using the same manufacturing process and same well known and well-established material as the predicate device; therefore, we reason it was not necessary to re-test biocompatibility in order to support the biological safety of the EK Digital Abutment. 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 and abutment system. Therefore, no additional biocompatibility testing is required to establish substantial equivalence.
Sterilization Validation
The EK Digital Abutment are manufactured by the predicate device manufacturing process, material and utilizes the same packing materials) are not sterilized like the predicate devices listed in this submission. Like the predicate devices the proposed can be moist heat sterilized and was validated following ISO 17665-1 [2006] Sterilization of health care products - 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 Digital Abutments.
Shelf Life
The EK Digital Abutment 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 non-mechanical, non-active materials therefore, degradation in performance characteristics is not likelv.
Surface Treatment Characterization Testing
The EK Digital Abutment are manufactured by the predicate device manufacturer, with surfaces using the same manufacturing process, material and surface finishing as the predicate devices listed in this submission. No additional character testing was necessary to support the equivalency of the EK Digital Abutments.
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Image /page/9/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 letters in gray. The word "Implant" is written in smaller gray letters below the word "Hiossen". The logo is simple and modern.
Mechanical Properties
The EK Digital Abutment System Mechanical testing was conducted in accordance to ISO 14801 Dentistry -Fatique Test for Endosseous Dental Implants. The worst case implant and titanium 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 Digital Abutment has the same design, intended use, structure, diameters, lengths, material surface, sterilization and packaging as the predicate devices listed in this submission 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.