ET Hybrid Abutment
Device Facts
| Record ID | K170421 |
|---|---|
| Device Name | ET Hybrid Abutment |
| Applicant | Hiossen, Inc. |
| Product Code | NHA · Dental |
| Decision Date | Jan 11, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Indications for Use
ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.
Device Story
Device is a two-piece customized dental abutment system consisting of a pre-manufactured titanium alloy 'ET Link Abutment' and a customized zirconia coping. Used in dental clinics to support prosthetic restorations (crowns/bridges) on Hiossen ET dental implants. Design input provided by dental laboratories or Hiossen via CAD software; final manufacturing, bonding, and quality control performed exclusively by Hiossen. Provides flexibility for angulation (0-30°) and customized gingival/post dimensions. Clinicians use the device to restore patient dentition; output is a patient-specific abutment assembly that integrates with the implant to provide structural support for the final prosthesis.
Clinical Evidence
No clinical studies submitted. Evidence relies on bench testing, including static and dynamic fatigue testing conducted in saline at 2Hz per ISO 14801, and biocompatibility/sterilization data leveraged from predicate devices.
Technological Characteristics
Two-piece abutment system (Link Abutment + Coping). Materials: Titanium Alloy (Ti-6AL 4V) and Zirconia Oxide. Angulation: 0-30°. Dimensions: Gingival diameter 4.2-15mm, total height 4.5-16mm. Sterilization: Steam sterilization (ISO 17665-1, ISO/TS 17665-2). Connectivity: CAD/CAM design input.
Indications for Use
Indicated for patients requiring screw-retained or cement-retained single tooth or bridge restorations in the edentulous or partially edentulous maxilla or mandible using HIOSSEN ET dental implants.
Regulatory Classification
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.
Special Controls
*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.)
Predicate Devices
- ET Hybrid Abutment (K162390)
Reference Devices
Submission Summary (Full Text)
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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
January 11, 2018
HIOSSEN Inc. David Kim Regulatory Affair Manager 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K170421
Trade/Device Name: ET Hybrid Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 12, 2017 Received: December 12, 2017
# Dear David Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows the logo and contact information for Hiossen Inc. The logo features the company name in a stylized font, with the letters "HI" in red and the rest of the name in gray. Below the logo is the company's address, which is 85 Ben Fairless Dr. Fairless Hills, PA 19030, along with their phone number, 1-888-678-0001, fax number, 1-267-759-7004, and website, www.hiossen.com.
# Indications for Use Statement
K170421 510(k) Number
Device Name : ET Hybrid Abutment
Indication for use : ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.
Prescription Use_ X (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/2 description: The image shows the logo for Hiossen. The word "Hiossen" is written in a stylized font. The "H" and "I" are in red, and the rest of the word is in gray. There is a red swoosh above the "H" and "I".
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel:1-888-678-0001 / Fax: 1-267-759-7004 www.hiossen.com
# 510 (K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
# Date : Jan. 11, 2018
### 1. Company and Correspondent making the submission:
| - Submitter's Name : | HIOSSEN IINC. |
|----------------------|--------------------------------------------------|
| - Address : | 85 Ben Fairless Dr. Fairless Hills, PA 19030 USA |
| - Contact : | Mr. David Kim |
| - Telephone No. | 888 678 0001 |
# 2. Device:
| Trade or (proprietary) Name: | ET Hybrid Abutment |
|-------------------------------|------------------------------------|
| Common or usual Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Classification: | Class II |
| Product Code: | NHA |
# 3. Predicate Device:
- 1) Primary : ET Hybrid Abutment K162390 / Hiossen, Inc.
- 2) Reference: Straumann Variobase Abutments (K132219, Institut Straumann AG)
- 3) Reference: ET SmartFit Abutment (K123627, Hiossen Inc.)
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Image /page/4/Picture/1 description: The image shows the logo for HIOSSEN. The logo is in two colors, red and gray. The letters "HI" are in red, and the rest of the word "OSSEN" is in gray. There is a red swoosh above the "O" in "OSSEN".
85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
# 4. Description:
ET Hybrid Abutment is intended to be placed onto Hiossen dental implants to provide support for customized prosthetic restorations such as crowns and bridges. The proposed devices are composed of ET Link Abutment and Coping. The ET Link Abutment is premanufactured abutment by Hiossen Inc. only and the coping would be manufactured and bonded into the ET Link Abutment by Hiossen only with design input using CAD software from both by dental laboratories and by Hiossen Inc. The final device of ET Hybrid Abutment is under controlled by Hiossen's Quality System and provided to the customer. ET Hybrid Abutment is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. Titanium alloy is the raw material for the Link Abutment and Zirconia material is for the Coping. The ET Hybrid Abutment gives the flexibility to design customized prosthetics.
| Code | ETCMAMNZS | ETCMAMHZS | ETCMARNZS | ETCMARHZS |
|-----------------------|-------------------|-----------|-------------------|-----------|
| (A) Angulation | 0~30(°) | | 0~30(°) | |
| (B) Gingival Diameter | 4.2~15 (mm) | | 4.7~15 (mm) | |
| (C)Total Height | 4.5~16(mm) | | 4.5~16(mm) | |
| (D)Contact Diameter | Ø4.2 | | Ø4.7 | |
| (E)Wall Thickness | Minimum 0.35 (mm) | | Minimum 0.44 (mm) | |
| (F)Gingival Height | 0.5~8.0 (mm) | | 0.5~8.0 (mm) | |
| (G)Post Diameter | 2.0~6.5 (mm) | | 3.0~9.0(mm) | |
| (H)Post Height | 4~16(mm) | | 4~16(mm) | |
The design limitation for coping is defined as below.
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Image /page/5/Picture/1 description: The image shows the word "HIOSSEN" in a stylized font. The "HI" portion of the word is in red, and there is a red curved line above the "I". The rest of the word, "OSSEN", is in gray. The font is bold and sans-serif.
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
The proposed devices are compatible with the implant systems below.
| No. | 510(K) | Proprietary name | Manufacture |
|-----|---------|----------------------------|--------------|
| 1 | K101096 | ET III SA Fixture System | HIOSSEN. Inc |
| 2 | K103537 | ETIII SA Ultra Wide System | HIOSSEN. Inc |
| 3 | K112532 | ET III BA Fixture System | HIOSSEN. Inc |
| 4 | K123471 | ETII SA FIXTURE SYSTEM | HIOSSEN. Inc |
| 5 | K140934 | HIOSSEN IMPLANT SYSTEM | HIOSSEN. Inc |
| 6 | K151626 | ET III NH System | HIOSSEN. Inc |
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Image /page/6/Picture/0 description: The image contains the word "HIOSSEN" in a stylized font. The "HI" is in red, and the "OSSEN" is in gray. There is a red swoosh above the "H" that connects to the "I".
#### Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel:1-888-678-0001 / Fax: 1-267-759-7004 www.hiossen.com
# Substantial Equivalence Matrix
| Part Name | Proposed devices | Primary predicate devices | Reference Predicates | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Part Name | ET Hybrid Abutment | ET Hybrid Abutment | Straumann Variobase<br>Abutments | ET Smartfit Abutment |
| 510K | Proposed | K162390 | K132219 | K123627 |
| Material | Titanium Alloy Ti-6AL 4V<br>Zirconia Oxide | Titanium Alloy Ti-6AL 4V<br>Zirconia Oxide | Titanium Alloy Ti-6AL 4V<br>Zirconia Oxide | Titanium Alloy<br>Ti-6AL 4V |
| Manufacturer | HIOSSEN INC. | HIOSSEN INC. | Institut Straumann AG | HIOSSEN INC. |
| Description | ET Hybrid Abutment is intended to be<br>placed onto Hiossen dental implants<br>to provide support for customized<br>prosthetic restorations such as crowns<br>and bridges. The proposed devices are<br>composed of ET Link Abutment and<br>Coping. The ET Link Abutment is<br>pre-manufactured abutment by<br>Hiossen Inc. only and the coping<br>would be manufactured and bonded<br>into the ET Link Abutment by<br>Hiossen only with design input using<br>CAD software from both by dental<br>laboratories and by Hiossen Inc. The<br>final device of ET Hybrid Abutment<br>is under controlled by Hiossen's<br>Quality System and provided to the<br>customer. | ET Hybrid Abutment is intended to be<br>placed onto Hiossen dental implants<br>to provide support for customized<br>prosthetic restorations such as crowns<br>and bridges. The proposed devices are<br>composed of ET Link Abutment and<br>Coping. The ET Link Abutment is<br>pre-manufactured abutment by<br>Hiossen Inc. only and the coping<br>would be manufactured by Hiossen<br>only with design input using CAD<br>/CAM software from both by dental<br>laboratories and by Hiossen Inc. The<br>final device of ET Hybrid Abutment<br>is under controlled by Hiossen's<br>Quality System and provided to the<br>customer. | The Straumann Variobase<br>Abutments are pre-manufactured<br>(stock) abutments, sometimes<br>referred to as "Ti-bases".<br>Straumann Variobase Abutments<br>are available to fit Straumann<br>dental implant platforms NNC<br>(Narrow Neck CrossFit), RN<br>(Regular Neck), WN (Wide Neck),<br>NC (Narrow CrossFit), and RC<br>(Regular CrossFit). A dental<br>laboratory technician would design<br>the corresponding coping and/or<br>crown (the second component of<br>the Variobase two-piece<br>abutment) and/or prosthetic<br>restoration in the dental laboratory | The ET SmartFit Abutment is<br>device made of titanium alloy<br>intended for use as an aid in<br>prosthetic restoration. That is<br>customized abutment considering<br>shape of the finial prosthesis<br>based on the patient's mouth<br>model using CAD/CAM system<br>during the manufacturing.<br>The ET SmartFit Abutment is<br>used for cement-retained crowns<br>and bridges using customized<br>abutment considering based on<br>the patient's mouth using<br>CAD/CAM system. |
| Description<br>(Continue) | ET Hybrid Abutment is indicated for<br>screw-retained single tooth or cement-<br>retained single tooth and bridge<br>restorations. The ET Hybrid Abutment<br>gives the flexibility to design<br>customized prosthetics. | ET Hybrid Abutment is indicated for<br>screw-retained single tooth or cement-<br>retained single tooth and bridge<br>restorations. The ET Hybrid Abutment<br>gives the flexibility to design<br>customized prosthetics. The coping is<br>straight only and the ET Link abutment<br>is not intended to provide an angle<br>and/or divergence correction. | using either a burnout coping or<br>STL model for open CAD software.<br>The coping and/or crown would be<br>manufactured via validated. | Use only the basal screws provide<br>for the Custom Abutment. The<br>surgical procedure for custom<br>abutment is the same as the surgical<br>procedure for the cement- retained<br>abutments. |
| Indication<br>for use | ET Hybrid Abutment is a customized<br>abutment intended for use with<br>HIOSSEN ET dental implant in the<br>edentulous or partially edentulous<br>maxilla or mandible to provide support<br>for prosthetic restorations such as<br>crowns and bridges. All digitally<br>designed copings for use with the ET<br>Hybrid Abutment for CAD are<br>intended to be sent to a HIOSSEN Inc.<br>manufacturing facility for manufacture. | ET Hybrid Abutment is a customized<br>abutment intended for use with<br>HIOSSEN ET dental implant in the<br>edentulous or partially edentulous<br>maxilla or mandible to provide support<br>for prosthetic restorations such as<br>crowns and bridges. All digitally<br>designed copings for use with the ET<br>Hybrid Abutment for CAD are<br>intended to be sent to a HIOSSEN Inc.<br>manufacturing facility for manufacture. | The Straumanho Variobase' Abutment<br>is a titanium base placed onto<br>Straumann dental implants to provide<br>support for customized prosthetic<br>restorations. Straumann Variobase<br>Abutments are indicated for screw-<br>retained single tooth or cement-<br>retained single tooth and bridge<br>restorations. | ET SmartFit Abutment is intended for<br>use with a dental implant to provide<br>support for prosthetic restorations<br>such as crowns, bridges, or<br>overdentures. |
| Design | Image: Two-piece Type [Abutment + Screw] | Image: Two-piece Type [Abutment + Screw] | Image: Two-piece Type [Abutment + Screw] | Image: Two-piece Type [Abutment + Screw] |
| Diameter (mm) | Ti- Base: 4.0/4.5<br>Two-piece: 4.2~15 | Ti- Base: 4.0/4.5<br>Two-piece : 4.2~15 | Ti- Base : 2.8~3.3<br>Two piece : N/A | 4~15 |
| Height (mm) | Ti- Base : 3.2<br>Two-piece : 4.5~16 | Ti- Base : 3.2<br>Two-piece : 4.5~16 | Ti-Base : 3.5<br>Two piece : N/A | 3~18 |
| Angle (°) | 0 ~ 30 | 0 | 0 ~ 30 | 0 ~ 30 |
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Image /page/7/Picture/0 description: The image shows the word "HIOSSEN" in a stylized font. The "HI" is in red, and the "OSSEN" is in gray. The "H" and "I" are connected, and there is a red swoosh above the "H".
Hiossen Inc.
85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel:1-888-678-0001 / Fax: 1-267-759-7004 www.hiossen.com
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Image /page/8/Picture/0 description: The image shows the Hiossen logo. The "HI" part of the logo is in red, and the "OSSEN" part is in gray. There is a red swoosh above the "HI" part of the logo.
# Ben Fairless Dr. Fairless Hills. PA 19030 1-888-678-0001 / Fax :- 1-267-759-7004
www.hiossen.com
The propose device has the similar intended use for, technological characteristics as predicate devices, ET Hybrid Abutment(K162390) and ET SmartFit Abutnent(K123627) by Hossen.Inc. , Straumann Variobase Abutment(K132219) of Institut Straumann AG. Those devices are the customized abuttrent devices. Especially, the ET Hybrid Abutnent system K162390. Primary predicate) and Variobase Abutments system K132219, Reference predicate) are similar process. The Ti-base(or in pre-milled and made of titaniumnaterial and coping part is designed by the clent al laboratory and nanufacturer using the CAD software and milled and bonded into ET Link Abutment by manufacture only. The only differences with S.E the reference predicate (Variobase Abutnent,K13219) are connection shapes. The shape are only for the manufacturer's properties such as design and compatible to their own dental implant design. The primary precicate (ET Hybrid Abutment, K162390) is almost same structure and dimension but it's straight only which is no angulation compensation and gingival height range. The second reference predicate (ET SmartFit, K123627) has same manufacturing process and facility, similar dimensions but only difference is a material on the top ( Zironia vs Titanium). This proposed device is manufactured using identical material and manufacturing process to a previously cleared predicates.
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Image /page/9/Picture/1 description: The image shows the logo for Hiossen Implant. The logo is composed of the word "Hiossen" in a stylized font. The "H" and the top part of the "i" are in red, while the rest of the word is in gray. The logo is simple and modern, and the use of color helps to make it stand out.
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
## 5. Indication for use :
ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.
# 6. Technological Characteristics
The proposed device has similar technological characteristics as the predicate device of the ET Hybrid Abutments (K162390) of Hiossen, Inc.. ET Hybrid Abutment and predicate device are composed of ET Link Abutment and Coping. ET Link Abutment is premanufactured abutment made with Titanium allov and Coping is customized with Zirconia. The only difference is the angle of coping part.
## 7. Summary of nonclinical testing
The following nonclinical testing data were provided or relied upon in support of the substantial equivalence determination.
## 1) Biocompatibility
Hiossen. Inc predicate K162390 was relied upon for biocompatibility. The subject device is manufactured using identical materials and manufacturing processes to a previously cleared predicates identified above. No additional biocompatibility testing was necessary for this device. The chemical composition, body contact and sterilization method are the same as the predicate devices. (Category: Implant Device. Contact: BONE / TISSUE. Contact Duration: C-Permanent More than 30 days )
# 2) Fatigue testing
Additional non-clinical testing data submitted to demonstrate substantial equivalence includes static and dynamic fatigue test according to ISO 14801 in saline at 2Hz on the final finished sterilized abutment.
### 3) Sterilization Validation
For the subject device, it is same in material(Titanium & Zirconia, Cement). This test had been conducted using worst case sample which is the longest height and the largest diameter. But only difference in between the proposed device and primary predicate device is angulation. Therefore, no additional testing is required. The steam sterilization validation for the predicate device was conducted according to ISO 17665-1, ISO/TS 17665-2 for gravity displacement on wrapped condition.
## 8. Summary of clinical testing
No clinical studies are submitted
### 9. Conclusions
The documentation submitted in this premarket notification demonstrates that the ET Hybrid Abutment is substantially equivalent to the predicate devices.
