(157 days)
No
The summary describes a dental abutment and its manufacturing process using CAD/CAM software, but there is no mention of AI or ML being used in the design, manufacturing, or function of the device.
No
The device is described as a customized abutment for dental implants, providing support for prosthetic restorations. It is structural and restorative, not therapeutic, as it does not treat or cure a disease or condition.
No
Explanation: The device, ET Hybrid Abutment, is described as a customized abutment for dental implants designed to support prosthetic restorations. Its purpose is to provide structural support for crowns and bridges, not to diagnose a condition.
No
The device description clearly states the device is composed of physical components (ET Link Abutment and Coping) made of titanium alloy and zirconia, which are manufactured and provided to the customer. While CAD/CAM software is used for design input, the final device is a physical implant component, not software itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ET Hybrid Abutment is a dental implant component used to support prosthetic restorations (crowns and bridges) within the mouth. It is a physical device implanted into the jawbone.
- Intended Use: The intended use clearly states it's for providing support for prosthetic restorations in the maxilla or mandible. This is a structural and restorative function, not a diagnostic one performed on a sample outside the body.
- Device Description: The description details the materials and components of the abutment, focusing on its mechanical function and placement within the mouth.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health condition.
Therefore, the ET Hybrid Abutment falls under the category of a medical device used for restorative dentistry, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
NHA
Device 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 by Hiossen only with design input using CAD/CAM 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. The coping is straight only and the ET Link abutment is not intended to provide an angle and/or divergence correction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous or partially edentulous maxilla or mandible
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)
No clinical studies are submitted. Additional non-clinical testing data submitted to demonstrate substantial equivalence includes steam sterlization according to ISO 17665-1, ISO/TS 17665-2 for gravity displacement on unwarp condition. All tests were conducted in accordance with relative standards without any discrepancies.
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
§ 872.3630 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design that resembles an abstract bird or wing above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2017
HIOSSEN Inc. Mr. David Kim RA Manager 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K162390
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 30, 2016 Received: December 30, 2016
Dear Mr. 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.
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 (reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -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
2
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 "H" and part of the "I" in red. Below the logo is the company name, address (85 Ben Fairless Dr. Fairless Hills, PA 19030), phone number (1-888-678-0001), fax number (1-267-759-7004), and website (www.hiossen.com).
Indications for Use Statement
510(k) Number K_162390
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)
3
Image /page/3/Picture/1 description: The image shows the logo and contact information for Hiossen Inc. The logo is in red and gray, and the text includes the company name, address (85 Ben Fairless Dr. Fairless Hills, PA 19030), phone number (1-888-678-0001), fax number (1-267-759-7004), and website (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. 26, 2017
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:
Primary : K132219 / Straumann Variobase Abutments / Institut Straumann AG Reference : K100245 / HS/HG Prosthetic System / Osstem Implant Co., Ltd. Reference : K123627 / ET Smartfit Abutment / HIOSSEN INC.
4
Image /page/4/Picture/1 description: The image contains the logo for Hiossen Implant. The logo is composed of the word "Hiossen" in a stylized font. The "H" and part of the "i" are in red, while the rest of the word is in gray. The font is bold and modern, giving the logo a clean and professional look.
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 by Hiossen only with design input using CAD/CAM 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. The coping is straight only and the ET Link abutment is not intended to provide an angle and/or divergence correction.
| Code | ETCMAMNZS / ETCMAMHZS | ETCMARNZS, ETCMARHZS |
|---|---|---|
| Diameter (D) | 4.2~15 (mm) | 4.7~15 (mm) |
| Wall Thick. | 0.35~0.55(mm) | 0.40~0.65 (mm) |
| Post Height(H) | 4~16 (mm) | 4~16 (mm) |
| Post Wall Thick.(t) | 0.7~2.7 (mm) | 1.2~4.2 (mm) |
| Post Diameter (d) | 2.5~6.5 (mm) | 3.0~9.0 (mm) |
| Gingival Margin | ||
| Height ( G/H ) | 3.5~8.5 (mm) | 3.5~8.5 (mm) |
The design limitation for coping is defined as below.
The coping is straight only and the ET Link abutment is not intended to provide an angle and/or divergence correction.
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 Bio-SA 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 |
5
Image /page/5/Picture/0 description: The image shows the logo and contact information for Hiossen Inc. The logo features the company name in a stylized font, with a red accent mark above the "H". The contact information includes the company's address at 85 Ben Fairless Dr. Fairless Hills, PA 19030, phone number 1-888-678-0001, fax number 1-267-759-7004, and website address www.hiossen.com.
- Substantial Equivalence Matrix
| Part Name | Proposed devices
ET Hybrid Abutment | Primary predicate devices
Straumann Variobase
Abutments | Reference predicate devices
The HS/HG Prosthetic System | Reference predicate devices
ET Smartfit Abutment |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K | Proposed | K132219 | K100245 | K123627 |
| Material | Titanium Alloy
Ti-6AL 4V | Titanium Alloy
Ti-6AL 4V | Titanium Alloy
(most abutments in the submission)
Zirconia
(Ziocera angled abutment) | Titanium Alloy
Ti-6AL 4V |
| Manufacturer | HIOSSEN INC. | Institute Straumann AG | Osstem Implant Co., Ltd | HIOSSEN INC |
| 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 pre-
manufactured abutment by Hiossen Inc.
only and the coping would be
manufactured by Hiossen only with
design input using CAD/CAM 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. The coping is
straight only and the ET Link abutment
is not intended to provide an angle
and/or divergence correction. | The Straumann Variobase
Abutments are pre-manufactured
(stock) abutments, sometimes
referred to as "Ti-bases".
Straumann Variobase Abutments
are available to fit Straumann
dental implant platforms NNC
(Narrow Neck CrossFit), RN
(Regular Neck), WN (Wide
Neck), NC (Narrow CrossFit),
and RC (Regular CrossFit).
A dental laboratory technician
would design the corresponding
coping and/or crown (the second
component of the Variobase two-
piece abutment) and/or prosthetic
restoration in the dental
laboratory using either a burnout
coping or STL model for open
CAD software.
The coping and/or crown would
be manufactured via validated
Straumann milling. | The HS/HG Prosthetic System is
device made of titanium, titanium
alloy, POM and PC and Zirconia
intended for use as an aid in
prosthetic restoration. It consists
of Abutment, Protect Cap and/or
Abutment Screw. Their surfaces
are partially Tin coated and
uncoated.
The HS/HG Prosthetic System is
similar to other commercially
available products based on the
intended use, the technology used,
the claims, the material
composition employed and
performance characteristics.
Use the ZioCera Abutment for
implant restoration of single
tooth or multiple teeth and for
aesthetic restoration or when
existing metal abutment cannot
be used. | The ET SMARTFit Abutment is
device made of titanium alloy
intended for use as an aid in
prosthetic restoration. That is
customized abutment considering
shape of the finial prosthesis
based on the patient's mouth
model using CAD/CAM system
during the manufacturing .
The ET SMARTFit Abutment is
used for cement-retained crowns
and bridges using customized
abutment considering based on
the patient's mouth using
CAD/CAM system.
Use only the basal screws provide
for the Custom Abutment. The
surgical procedure for custom
abutment is the same as the
surgical procedure for the cement-
retained abutments. |
| 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. | The Straumann Variobase'
Abutment is a titanium base
placed onto Straumann dental
implants to provide support for
customized prosthetic
restorations. Straumann
Variobase Abutments are
indicated for screw-retained
single tooth or cement-retained
single tooth and bridge
restorations. | HS/HG Prosthetic System is
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. |
| Design | Two-piece Type | Two-piece Type | One-piece Type | One-piece Type |
| Diameter (mm) | Ti- Base: 4.0/4.5
Two-piece : 4.215 | Ti- Base : 2.83.3
Two-piece : N/A | 5.5/6.5 | 415 |16 | Ti-Base : 3.5
| Height (mm) | Ti- Base : 3.2
Two-piece: 4
Two-piece : N/A | 3.0, 4.0 (G/H) | 3~18 |
6
Image /page/6/Picture/0 description: The image shows the logo for Hiossen Inc. The word "HIOSSEN" is written in a stylized font, with the "HI" in red and the rest of the word in gray. The words "Hiossen Inc." are written in black below the logo.
85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
7
Image /page/7/Picture/0 description: The image shows the Hiossen Inc. logo. The "HI" part of the logo is in red, while the "OSSEN" part is in gray. The text "Hiossen Inc." is written below the logo.
85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004
SECTION 007
ET Hybrid Abutment has the similar intended use for, technological characteristics as predicate devices, K132219 Straumann Variobase Abutments (K132219) of Institut Straumann AG. Both devices are customized abutments. Especially Variosbase abutment and the subject devices are similar manufacturing processes. The Ti-base part is pre-milled and made ial and coping SE is designed by the dental laboratory and manufacturer using the CAD software and milled by manufacturer only. The only differences are connection structure and insignificant shapes. The connection and shape are only for the manufacturer's design and compatible to their own dental implant design. The ET Smart Fit abutment as the same manufacturing process and facility, similar dimensions but only difference is a material on the top (Zirconia vs Titanium ). The zirconia material is widely used in the Dental industry and the materials similarity is applicable to the Zirconia abutment (HS/HG Prosthetic System, K100245). This subject device is manufactured using identical materials and manufacturing processes to a previously cleared predicate.
8
Image /page/8/Picture/0 description: The image shows the logo and contact information for Hiossen Inc. The logo features the company name in a stylized font, with the "H" 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, as well as their phone number, 1-888-678-0001, fax number, 1-267-759-7004, and website, www.hiossen.com.
- 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 same technological characteristics as the predicate device of K132219) of Institut Straumann AG. ET Hybrid Abutment and predicate device are composed of ET Link Abutment and Coping. ET Link Abutment is pre-manufactured abutment made with Titanium alloy and Coping is customized with Zirconia. The only differences are connection structure and insignificant shapes.
7. Summary of nonclinical testing
Hiossen, Inc. predicate K123627 and K100245 was relied upon for biocompatibility. The subject device is manufactured using identical materials and manufacturing processes to a previously cleared predicates below. No additional biocompatibility testing was necessary for this device. The chemical composition, body contact and sterilization method are the predicate devices. (Category: Implant Device, Contact: BONE / TISSUE, Contact Duration: C-Permanent More than 30 days ) Additional non-clinical testing data submitted to demonstrate substantial equivalence includes steam sterlization according to ISO 17665-1, ISO/TS 17665-2 for gravity displacement on unwarp condition. All tests were conducted in accordance with relative standards without any discrepancies.
| TEST ITEM | STANDARD |
|---|---|
| Steam sterilization Validation | ISO 17665-1, ISO/TS 17665-2 |
9
Image /page/9/Picture/0 description: The image shows the logo and contact information for Hiossen Inc. The logo features the company name in a stylized font, with the "H" 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, as well as their phone number, 1-888-678-0001, fax number, 1-267-759-7004, and website, www.hiossen.com.
-
Summary of clinical testing No clinical studies are submitted.
-
Conclusions
The documentation submitted in this premarket notification demonstrates that the ET Hybrid Abutment is substantially equivalent to the predicate devices.