(240 days)
No
The summary describes a mechanical dental abutment system made of titanium alloy. There is no mention of software, image processing, AI, ML, or any data-driven components. The performance studies are focused on mechanical and material properties.
No
This device is a prosthetic support system (dental abutment) used with dental implants to hold crowns, bridges, and overdentures, not to treat or cure a disease or condition.
No
The device is an abutment system for dental implants used to support prosthetic restorations, not to diagnose medical conditions.
No
The device description explicitly states the device is "Manufactured from medical grade titanium alloy" and describes physical components (abutments in various lengths and diameters), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The ET Abutment System is a physical device implanted into the body to support dental prosthetics. It is used in vivo (within the body).
- Intended Use: The intended use is to provide structural support for dental restorations in patients, not to analyze biological samples.
The information provided clearly describes a medical device used directly in a patient's mouth, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The ET Abutments are indicated for use with ET Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
Product codes
NHA
Device Description
The ET Abutment System are indicated for use with ET dental implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized.
The ET Abutments are available in various lengths and diameters; configurations are listed in the table below.
| EK DENTAL ABUTMENTS | Diameter (mm) | Length (mm) |
|---|---|---|
| ET Angled | 4.0 ~ 6.0 | 13.0, 15.0 |
| ET Convertible Angled Cylinder | 4.0, 4.8, 6.0 | 7.5 |
| ET Goldcast | 4.0, 4.5 | 13.0 ~ 16.0 |
| ET Multi Angled | 4.80 | 9.00 ~ 13.00 |
| ET Multi Combination Cylinder | 5.00 | 7.30 |
| ET O-ring | 3.50, 4.60 | 1.15, 1.50 |
| ET Retainer, Retainer Cap | 5.00 | 4.40 |
| ET Port | 3.70 | 7.00 ~ 13.00 |
| ET Male Cap | 5.50 | 2.25 |
| ET Males | 4.75 | 1.80 |
| ET Stud | 3.50 | 9.00 ~ 15.00 |
| ET Temporary | 4.00, 4.50 | 13.00 ~ 16.00 |
| ET Transfer | 4.00 ~ 7.00 | 8.00 ~ 15.00 |
| ET Freeform ST | 4.00 ~ 7.00 | 14.00, 15.00 |
| ET Rigid | 4.00 ~ 7.00 | 4.00, 5.50, 7.00 |
| ET Rigid Protect Cap | 4.00 ~ 7.00 | 4.00, 5.50, 7.00 |
| ET Esthetic Low Temporary Cylinder | 4.80, 5.30 | 12.00 |
| ET Multi | 4.80 | 9.00 ~ 13.00 |
| ET Esthetic Low Gold Cylinder | 4.80 | 12.00 |
| ET Convertible Combination Cylinder | 4.00, 4.80, 6.00 | 7.00 |
| ET Convertible Temporary Cylinder | 4.00, 4.80, 6.00 | 9.80 |
| ET Convertible | 4.00, 4.80, 6.00 | 6.00 ~ 11.00 |
| ET Convertible GoldCast Cylinder | 4.00, 4.80, 6.00 | 11.75, 12.15 |
| ET Convertible Plastic Cylinder | 4.00, 4.80, 6.00 | 12.00 |
| ET Convertible Protect Cap | 4.00, 4.80, 6.00 | 2.90, 3.50 |
| ET Esthetic Low Plastic Cylinder | 4.80 | 12.00 |
| ET Esthetic Low Healing Cap | 4.80 | 4.60 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous patients (mandibles and maxillae)
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 ET Abutment System are contract manufactured by the predicate device manufacturer using the same manufacturing process and same well known and wellestablished 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 ET Abutment System. The proposed devices are manufactured from standard raw material that are used in the primary predicate device and other currently marketed dental implant and abutment system. Therefore, no additional biocompatibility testing is required to establish substantial equivalence.
Sterilization Validation:
The ET Abutment System (are contractured by the predicate device manufacturer using the same manufacturing process, material and utilizes the same packing materials) are 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 — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, therefore we reason it was not necessary to re-test validation in order to support sterilization validity of the ET Abutment System.
Shelf Life:
The ET Abutment System 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 ET Abutment System are contractured 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 ET Abutment System.
Mechanical Properties:
The ET Abutment System fatique testing of the worst case scenario was conducted per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments. Proposed dental attachments are contract manufactured by the predicate device manufacturer using the same manufacturing process, material and same design, as the predicates listed in this submission which were fatigue tested in accordance with ISO 14801 Dentistry - Fatique Test for Endosseous Dental Implants.
MRI Compatibility:
K221684 has cleared the contract manufacturer's support for the MRI compatibility of the ET Abutment System. This clearance indicates that a non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., 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 bodies, 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)
K161689, K160670, K140507, K120847, K110308, K100245, K081575, K073247, K062030, K182091
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/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Hiossen Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K222636
Trade/Device Name: ET Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 30, 2023 Received: April 3, 2023
Dear Peter Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K222636
Device Name
ET Abutment System
Indications for Use (Describe)
The ET Abutments are indicated for use with ET Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
Type of use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 807 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Service (301) 443-6740 EF
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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 letters. The word "OSSEN" is in gray, and the word "IMPLANT" is in a smaller font below the word "OSSEN". There is a registered trademark symbol to the right of the word "OSSEN".
85 Ben Fairless Drive s Hills, PA 19030 888-768-0001 www.hiossen.com
Section 6 510(k) Summary - 12 PAGES
| 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: | April 28, 2023 |
| 6.2 Device Name:
• Proprietary Name:
• Classification Name: | ET Abutment System
Implant, Endosseous, Root |
| • Proprietary Name: | ET Abutment System |
|---|---|
| • Classification Name: | Implant, Endosseous, Root-form |
| • CFR Number: | 872.3630 |
| • Device Class: | Class II |
| • Product Code: | NHA |
6.3 Predicate Devices:
| Primary | 510(k) | Manufacturer(s) |
|---|---|---|
| Osstem Abutment System | K182091 | Osstem Implant Co., Ltd. |
| Reference | 510(k) | Manufacturer(s) |
| Osstem Implant System - Abutment | K161689 | Osstem Implant Co., Ltd. |
| ET US SS Prosthetic System | K160670 | Osstem Implant Co., Ltd. |
| Hiossen Prosthetic System | K140507 | Osstem Implant Co., Ltd. |
| ET/SS Implant System | K120847 | Osstem Implant Co., Ltd. |
| Prosthetic System | K110308 | Osstem Implant Co., Ltd. |
| HS/HG Prosthetic System | K100245 | Osstem Implant Co., Ltd. |
| HU/HS/HG Prosthetic System | K081575 | Osstem Implant Co., Ltd. |
| US/SS/GS System | K073247 | Osstem Implant Co., Ltd. |
| US System | K062030 | Osstem Implant Co., Ltd. |
6.4 Description of Device:
The ET Abutment System are indicated for use with ET dental implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized.
The ET Abutments are available in various lengths and diameters; configurations are listed in the table below.
| EK DENTAL ABUTMENTS | Diameter (mm) | Length (mm) |
|---|---|---|
| ET Angled | 4.0 ~ 6.0 | 13.0, 15.0 |
| ET Convertible Angled Cylinder | 4.0, 4.8, 6.0 | 7.5 |
| ET Goldcast | 4.0, 4.5 | 13.0 ~ 16.0 |
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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 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 promote the company's dental implant products.
5 Ben Fairless Drive A 19030 www.hiossen.com
| ET Multi Angled | 4.80 | 9.00 ~ 13.00 |
|---|---|---|
| ET Multi Combination Cylinder | 5.00 | 7.30 |
| ET O-ring | 3.50, 4.60 | 1.15, 1.50 |
| ET Retainer, Retainer Cap | 5.00 | 4.40 |
| ET Port | 3.70 | 7.00 ~ 13.00 |
| ET Male Cap | 5.50 | 2.25 |
| ET Males | 4.75 | 1.80 |
| ET Stud | 3.50 | 9.00 ~ 15.00 |
| ET Temporary | 4.00, 4.50 | 13.00 ~ 16.00 |
| ET Transfer | 4.00 ~ 7.00 | 8.00 ~ 15.00 |
| ET Freeform ST | 4.00 ~ 7.00 | 14.00, 15.00 |
| ET Rigid | 4.00 ~ 7.00 | 4.00, 5.50, 7.00 |
| ET Rigid Protect Cap | 4.00 ~ 7.00 | 4.00, 5.50, 7.00 |
| ET Esthetic Low Temporary Cylinder | 4.80, 5.30 | 12.00 |
| ET Multi | 4.80 | 9.00 ~ 13.00 |
| ET Esthetic Low Gold Cylinder | 4.80 | 12.00 |
| ET Convertible Combination Cylinder | 4.00, 4.80, 6.00 | 7.00 |
| ET Convertible Temporary Cylinder | 4.00, 4.80, 6.00 | 9.80 |
| ET Convertible | 4.00, 4.80, 6.00 | 6.00 ~ 11.00 |
| ET Convertible GoldCast Cylinder | 4.00, 4.80, 6.00 | 11.75, 12.15 |
| ET Convertible Plastic Cylinder | 4.00, 4.80, 6.00 | 12.00 |
| ET Convertible Protect Cap | 4.00, 4.80, 6.00 | 2.90, 3.50 |
| ET Esthetic Low Plastic Cylinder | 4.80 | 12.00 |
| ET Esthetic Low Healing Cap | 4.80 | 4.60 |
The ET Abutment System are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
6.5 Indication for Use:
The ET Abutment System are indicated for use with ET dental implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.
6.6 Substantial Equivalence:
6.6.1 ET Abutment System
The information and date provided in this submission established the ET Abutment System are substantially equivalent to the primary predicate devices listed below. Proposed devices are the same devices Osstem (FEI 3003394081) received clearance listed as predicate and reference devices.
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" and the curved line above it in red, and the rest of the word in gray. Below the word "Hiossen" is the word "IMPLANT" in smaller, gray letters. The logo is simple and modern, and it is likely used to promote the company's dental implant products.
| Device | Proposed Device
ET Abutment System | Primary Predicate Devices
Osstem Abutment System |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K182091 |
| Intended use | The ET Abutments are indicated for use
with ET Dental Implants to provide support
to prosthetic restoration such as crowns,
bridges and overdentures in partially or fully
edentulous patients. | Osstem Abutment System is intended for
use with a dental implant to provide support
for prosthetic restorations such as crowns,
bridges, or overdentures.
• Link Abutment for CEREC |
| | | The Link Abutment for CEREC is titanium
alloy abutments placed onto OSSTEM
dental implants to provide support for
customized prosthetic restorations. Link
Abutment for CEREC is indicated for screw-
retained single tooth or cement-retained
single tooth and bridge restorations. All
digitally designed copings and/or crowns for
use with the Link abutment for CEREC is to
be scanned using Sirona CEREC AC or
CEREC AF or CEREC AI, designed using
Sirona inLab software (Version 3.65) or
Sirona CEREC Software (Version 4.2) and
manufactured using a Sirona CEREC or
inLab MC X or MC XL milling unit. CAD/CAM
manufacturing/milling occurs at dental
laboratories per the design limitations of the
Sirona CEREC. |
| Sterilization | • Delivered non-sterilized
• Steam sterilized by user | • Delivered non-sterilized
• Steam sterilized by user |
| Packaging | • Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. | • Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. |
| ET ANGLED | | |
| Design | | |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| Diameters(mm) | 4.0 ~ 6.0 | 4.0 ~ 6.0 |
| Heights(mm) | 8.0 | 8.0 |
| Angulation | 17° | 17° |
| ET CONVERTIBLE ANGLED CYLINDER | | |
| Design | | |
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Diameters(mm) | 4.0, 5.0 | 4.0, 5.0, 6.0 |
| Height(mm) | 8.0 | 8.0 |
| ET MULTI ANGLED | | |
| Design | Image: ET MULTI ANGLED | Image: ET MULTI ANGLED |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| Diameters(mm) | 4.8 | 4.8 |
| G/H(mm) | $2.5 ~ 5.0$ | $2.5 ~ 5.0$ |
| Angulation | $17°, 30°$ | $17°, 30°$ |
| ET MULTI COMBO CYLINDER | | |
| Design | Image: ET MULTI COMBO CYLINDER | Image: ET MULTI COMBO CYLINDER |
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Diameters(mm) | 5.0 | 5.0 |
| Height(mm) | 7.3 | 7.3 |
| ET PORT | | |
| Design | Image: ET PORT | Image: ET PORT |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| Diameters(mm) | 3.7 | 3.7 |
| G/H(mm) | $1.05.0$ | $1.05.0$ |
| ET Male Cap | | |
| Design | Image: ET Male Cap | Image: ET Male Cap |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| Diameters(mm) | 5.5 | 5.5 |
| Height(mm) | 2.25 | 2.25 |
| ET Port Males | | |
| Design | Image: ET Port Males | Image: ET Port Males |
| Material | • Nylon | • Nylon |
| Diameters(mm) | 4.73 | 4.73 |
| Height(mm) | 1.80 | 1.80 |
| ET Port Extended Males | | |
| Design | Image: ET Port Extended Males | Image: ET Port Extended Males |
| Material | • Nylon | • Nylon |
| Diameters(mm) | 4.75 | 4.75 |
| Height(mm) | 1.80 | 1.80 |
| ET STUD | | |
| Design | Image: ET STUD | Image: ET STUD |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| | | |
| Diameters(mm) | 3.5 | 3.5 |
| G/H(mm) | 1.0 ~ 6.0 | 1.0 ~ 6.0 |
| ET O-RING | | |
| Design | Image: ET O-RING Design | Image: ET O-RING Design |
| Material | • Acrylonitrile & Butadiene Polymer (NBR) | • Acrylonitrile & Butadiene Polymer (NBR) |
| Diameter | 3.50, 4.60 | 3.50, 4.60 |
| Height | 1.15, 1.50 | 1.15, 1.50 |
| ET RETAINER, CAP | | |
| Design | Image: ET RETAINER, CAP Design | Image: ET RETAINER, CAP Design |
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Diameter | 5.00 | 5.00 |
| Height | 2.00, 3.90 | 2.00, 3.90 |
| ET TEMPORARY | | |
| Design | Image: ET TEMPORARY Design | Image: ET TEMPORARY Design |
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 |
| Height(mm) | 10 | 10 |
| ET TRANSFER | | |
| Design | Image: ET TRANSFER Design | Image: ET TRANSFER Design |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136) | • Titanium alloy Ti-6Al-4V (ASTM F136) |
| Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 |
| Height(mm) | 4.0. 5.5. 7.0 | 4.0. 5.5. 7.0 |
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Image /page/6/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the word "Hiossen" in a stylized font, with the "H" in red and the rest of the word in gray. The word "Implant" is written in smaller gray letters below the word "Hiossen". The logo is simple and modern.
7
Image /page/7/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the word "Hiossen" in a stylized font, with the "H" in red and the rest of the word in gray. Below the word "Hiossen" is the word "IMPLANT" in a smaller, gray font. The logo is simple and modern, and it is likely used to represent a company that manufactures or sells dental implants.
| Device | Proposed Device
ET Abutment System | Reference Devices
Osstem Implant System - Abutment |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K161689 |
| Intended use | The ET Dental Abutments are indicated for
use with ET Dental Implants to provide
support to prosthetic restoration such as
crowns, bridges and overdentures in
partially or fully edentulous patients. | The OSSTEM Implant System - 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 | • 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. |
| ET FREEFORM ST | | |
| ET FREEFORM ST
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Image /page/8/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the word "Hiossen" in a stylized font, with the "H" and part of the "i" in red, and the rest of the word in gray. Below the word "Hiossen" is the word "Implant" in a smaller, gray font. 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
| Design | Image: Design | Image: Design |
|---|---|---|
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F 136) | • Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Max. Angulation | 17° | 17° |
| Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 |
| G/H(mm) | 1.5, 3.0 | 1.5, 3.0 |
| ET RIGID | ||
| Design | Image: Design | Image: Design |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F 136) | • Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 |
| Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |
| ET RIGID PROTECT CAP | ||
| Design | Image: Design | Image: Design |
| Material | • PolyCarbonate Polymer | • PolyCarbonate Polymer |
| Diameters(mm) | 4.0 ~ 7.0 | 4.0 ~ 7.0 |
| Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 |
| Device | Proposed Device
ET Abutment System | Reference Devices
ET US SS Prosthetic System |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K160670 |
| Intended use | The ET Dental Abutments are indicated for
use with ET Dental Implants to provide
support to prosthetic restoration such as
crowns, bridges and overdentures
in
partially or fully edentulous patients. | ET System
The HIOSSEN Prosthetic system is
intended for use with a dental implant to
provide support for prosthetic such as
crowns, bridges, or overdentures.
US/SS System
The OSSTEM Prosthetic system is intended
for use with a dental implant to provide
support for prosthetic such as crowns,
bridges, or overdentures. |
| Sterilization | • Delivered non-sterilized
• Steam sterilized by user | • Delivered non-sterilized
• Steam sterilized by user |
| Packaging | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. |
| ET ESTHETIC LOW TEMPORARY | | |
| Design | Image: ET ESTHETIC LOW TEMPORARY Design | Image: ET ESTHETIC LOW TEMPORARY Design |
| Surface | Machine surface | Machine surface |
9
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. Below the word "Hiossen" is the word "IMPLANT" in smaller, gray letters. The logo is simple and modern, and it is likely used to promote a dental implant company.
85 Ben Fairless Drive
Fairless Hills, PA 19030
888-768-0001
www.hiossen.com
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
|---|---|---|
| Diameters(mm) | 5.3, 4.8 | 5.3, 4.8 |
| Height(mm) | 12.0 | 12.0 |
| ET MULTI | ||
| Design | Image: dental implant | Image: dental implant |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F 136) | • Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Diameters(mm) | 4.8 | 4.8 |
| G/H(mm) | 1.0 ~ 5.0 | 1.0 ~ 5.0 |
| Device | Proposed Device
ET Abutment System | Reference Devices
Hiossen Prosthetic System |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K140507 |
| Intended use | The ET Dental Abutments are indicated for
use with ET Dental Implants to provide
support to prosthetic restoration such as
crowns, bridges and overdentures in
partially or fully edentulous patients. | The Hiossen Prosthetic System are
indicated for use with a dental implant to
provide support to prosthetic restoration
such as crowns, bridges and overdentures. |
| Material | • Gold alloy | • Gold alloy |
| Sterilization | • Delivered non-sterilized
• Steam sterilized by user | • Delivered non-sterilized
• Steam sterilized by user |
| Packaging | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. |
| | ET ESTHETIC LOW GOLD CYLINDER | |
| Design | | |
| | Image: ET ESTHETIC LOW GOLD CYLINDER | Image: ET ESTHETIC LOW GOLD CYLINDER |
| Max. Angulation | 0° | 0° |
| Diameters(mm) | 4.8 | 4.8 |
| Height(mm) | 12.0 | 12.0 |
| Device | Proposed Device
ET Abutment System | Reference Devices
ET/SS Implant System |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K120847 |
| Intended use | The ET Dental Abutments are indicated for
use with ET Dental Implants to provide
support to prosthetic restoration such as
crowns, bridges and overdentures
in
partially or fully edentulous patients. | The ET/SS 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. The abutment
is intended for use with a dental implant |
10
Image /page/10/Picture/0 description: The image shows the logo for Hiossen Implant. The logo features the letters "HI" in red, with a curved line extending from the top of the "H" over the "I". 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 smaller, gray letters.
| | | fixture to provide support for prosthetic
restorations such as crowns, bridges, or
overdenture. |
|---------------|------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Sterilization | • Delivered non-sterilized | • Delivered non-sterilized |
| | • Steam sterilized by user | • Steam sterilized by user |
| Packaging | • Secured in plastic ampule | • Secured in plastic ampule |
| | • Housed in Tyvek-lidded blister tray | • Housed in Tyvek-lidded blister tray |
| | • Placed in a tamper-evident outer
package. | • Placed in a tamper-evident outer
package. |
| | ET CONVERTIBLE COMBO CYLINDER | |
| Design | Image: [Design] | Image: [Design] |
| Diameters(mm) | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| Height(mm) | 7.0 | 7.0 |
| Device | Proposed Device
ET Abutment System | Reference Devices
ET/SS Implant System |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K110308 |
| Intended use | The ET Dental Abutments are indicated for
use with ET Dental Implants to provide
support to prosthetic restoration such as
crowns, bridges and overdentures in
partially or fully edentulous patients. | Prosthetic System 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 | • Secured in plastic ampule | • Secured in plastic ampule |
| | • Housed in Tyvek-lidded blister tray | • Housed in Tyvek-lidded blister tray |
| | • Placed in a tamper-evident outer
package. | • Placed in a tamper-evident outer
package. |
| ET GOLDCAST | | |
| Design | | |
| Max. Angulation | 30° | 30° |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F136)
• POM | • Titanium alloy Ti-6Al-4V (ASTM F136)
• POM |
| Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 |
| Device | Proposed Device
ET Abutment System | Reference Devices
HS/HG Prosthetic System |
|--------------|---------------------------------------|----------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K100245 |
11
Image /page/11/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". There is a registered trademark symbol next to the word "Hiossen".
| Intended use | The ET Dental Abutments are indicated for
use with ET Dental Implants to provide
support to prosthetic restoration such as
crowns, bridges and overdentures in
partially or fully edentulous patients. | HS/HG Prosthetic System is intended for
use with a dental implant to provide support
for prosthetic restorations such as crowns,
bridges, or overdentures. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Sterilization | • Delivered non-sterilized
• Steam sterilized by user | • Delivered non-sterilized
• Steam sterilized by user |
| Packaging | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. |
| ET CONVERTIBLE TEMPORARY CYLINDER | | |
| Design | | |
| Diameters(mm) | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| Height(mm) | 12.0 | 12.0 |
| Device | Proposed Device
ET Abutment System | Reference Devices
HU/HS/HG Prosthetic System |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K081575 |
| Intended use | The ET Dental Abutments are indicated for
use with ET Dental Implants to provide
support to prosthetic restoration such as
crowns, bridges and overdentures in
partially or fully edentulous patients. | HU/HS/HG Prosthetic System 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 | • 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. |
| ET CONVERTIBLE | | |
| Design | Image: ET Convertible Design | Image: HU/HS/HG Prosthetic System Design |
| Surface | Machine surface | Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F 136) | • Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Diameters(mm) | 4.0, 4.5 | 4.0, 4.5 |
| G/H(mm) | 1.0, 3.0 | 1.0, 3.0 |
| ET CONVERTIBLE GOLDCAST | | |
| Design | Image: ET Convertible Goldcast Design | Image: Unknown Design |
| Material | • Gold alloy | • Gold alloy |
| Max. Angulation | 0° | 0° |
12
Image /page/12/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 "Hiossen". There is a registered trademark symbol next to the word "Hiossen".
| Diameters(mm) | 4.0, 4.8, 6.0 | 4.0, 4.8, 6.0 |
|---|---|---|
| G/H(mm) | 11.75, 12.15 | 11.75, 12.15 |
| ET CONVERTIBLE PLASTIC | ||
| Design | Image: ET CONVERTIBLE PLASTIC Design | Image: ET CONVERTIBLE PLASTIC Design |
| Material | · Polyoxymethylene (POM) | · Polyoxymethylene (POM) |
| Max. Angulation | 0° | 0° |
| Diameters(mm) | 4.0, 5.0, 6.0 | 4.0, 5.0, 6.0 |
| G/H(mm) | 12.0 | 12.0 |
| ET CONVERTIBLE PROTECT CAP | ||
| Design | Image: ET CONVERTIBLE PROTECT CAP Design | Image: ET CONVERTIBLE PROTECT CAP Design |
| Surface | Machine surface | Machine surface |
| Material | · Titanium alloy Ti-6Al-4V (ASTM F 136) | · Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Diameters(mm) | 4.0, 4.8, 6.0 | 4.0, 4.8, 6.0 |
| Height(mm) | 2.9, 3.5 | 2.9, 3.5 |
| Device | Proposed Device
ET Abutment System | Reference Devices
US/SS/GS Prosthetic System |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K073247 |
| Intended use | The ET Dental Abutments are indicated for
use with ET Dental Implants to provide
support to prosthetic restoration such as
crowns, bridges and overdentures
in
partially or fully edentulous patients. | The US/SS/GS 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 terminal or intermediate abutment
support for fixed bridgework. The US/SS/GS
System is for single and two stage surgical
procedures. It is not for immediate load.. |
| Material | • Polyoxymethylene (POM) | • Polyoxymethylene (POM) |
| Sterilization | • Delivered non-sterilized
• Steam sterilized by user | • Delivered non-sterilized
• Steam sterilized by user |
| Packaging | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer
package. |
| ET ESTHETIC LOW PLASTIC CYLINDER | | |
| Design | Image: ET ESTHETIC LOW PLASTIC CYLINDER | Image: ET ESTHETIC LOW PLASTIC CYLINDER |
| Max. Angulation | 0° | 0° |
| Diameters(mm) | 4.80 | 4.80 |
| G/H(mm) | 12.00 | 12.00 |
| Device | Proposed Device | Reference Devices |
|---|---|---|
| ET Abutment System | US System |
13
Image /page/13/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the letters "HI" in red, with the rest of the word "OSSEN" in gray. Below the word "OSSEN" is the word "IMPLANT" in gray. The logo is simple and modern.
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
|---|---|---|
| 510(K) No. | New device | K062030 |
| Intended use | The ET Dental Abutments are indicated for | |
| use with ET Dental Implants to provide | ||
| support to prosthetic restoration such as | ||
| crowns, bridges and overdentures in | ||
| partially or fully edentulous patients. | US System and SSII mini are intended for | |
| use in partially or fully edentulous mandibles | ||
| and maxillae, in support of single or multiple- | ||
| unit restorations, and terminal or | ||
| intermediate abutment support for fixed | ||
| bridgework. US System is for two stage | ||
| surgical procedures. It is not for one stage | ||
| or immediate load. SSII mini is for one and | ||
| two stage surgical procedures. It is not for | ||
| immediate load. | ||
| Surface | Machine surface | Machine surface |
| Material | • Titanium CP Grade 3 | • Titanium CP Grade 3 |
| Sterilization | • Delivered non-sterilized | |
| • Steam sterilized by user | • Delivered non-sterilized | |
| • Steam sterilized by user | ||
| Packaging | • Secured in plastic ampule | • Secured in plastic ampule |
| • Housed in Tyvek-lidded blister tray | • Housed in Tyvek-lidded blister tray | |
| • Placed in a tamper-evident outer | ||
| package. | • Placed in a tamper-evident outer | |
| package. | ||
| ET ESTHETIC LOW HEALING | ||
| Design | Image: abutment | Image: abutment |
| Diameters(mm) | 4.80 | 4.80 |
| G/H(mm) | 4.60 | 4.60 |
| Device | Proposed Device
ET Abutment System | Reference Devices
US System |
|-----------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K182091 |
| Device
Description | Screw securing abutment to dental implant | Screw securing abutment to dental implant |
| Surface | • Machine surface | • Machine surface |
| Material | • Titanium alloy Ti-6Al-4V (ASTM F 136) | • Titanium alloy Ti-6Al-4V (ASTM F 136) |
| Sterilization | • Delivered non-sterilized
• Steam sterilized by user | • Delivered non-sterilized
• Steam sterilized by user |
| Packaging | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer package. | • Secured in plastic ampule
• Housed in Tyvek-lidded blister tray
• Placed in a tamper-evident outer package. |
| EBONY GOLD SCREW | | |
| Design | | |
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
14
Image /page/14/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the word "Hiossen" in a stylized font, with the "H" in red and the rest of the letters in gray. Below the word "Hiossen" is the word "IMPLANT" in smaller, gray letters. The logo is simple and modern, and it is likely used to promote the company's dental implant products.
ww.hiossen.com
The ET Abutment System are contract manufactured by the predicate device manufacturer using the same manufacturing process and same well known and wellestablished 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 ET Abutment System. The proposed devices are manufactured from standard raw material that are used in the primary predicate device and other currently marketed dental implant and abutment system. Therefore, no additional biocompatibility testing is required to establish substantial equivalence.
Sterilization Validation
The ET Abutment System (are contractured by the predicate device manufacturer using the same manufacturing process, material and utilizes the same packing materials) are 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 — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, therefore we reason it was not necessary to re-test validation in order to support sterilization validity of the ET Abutment System.
Shelf Life
The ET Abutment System 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 ET Abutment System are contractured 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 ET Abutment System.
Mechanical Properties
The ET Abutment System fatique testing of the worst case scenario was conducted per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments. Proposed dental attachments are contract manufactured by the predicate device manufacturer using the same manufacturing process, material and same design, as the predicates listed in this submission which were fatigue tested in accordance with ISO 14801 Dentistry - Fatique Test for Endosseous Dental Implants.
MRI Compatibility
K221684 has cleared the contract manufacturer's support for the MRI compatibility of the ET Abutment System. This clearance indicates that a non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., 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 bodies, 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.
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 ET Abutment System has the same design, intended use, structure, diameters, lengths, material surface, sterilization and packaging as the predicate
15
Image /page/15/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. Below the word "Hiossen" is the word "IMPLANT" in smaller, gray letters. The logo is simple and modern, and it is likely used to promote the company's dental implant products.
85 Ben Fairless Drive Fairless Hills, PA 19030 888-768-0001 www.hiossen.com
submission are are substantially
listed in this devices equivalent. The propose devices do not pose any new or increased risk as compared to both the legally marketed predicate and reference devices.