ET Abutment System

K222636 · Hiossen, Inc. · NHA · Apr 28, 2023 · Dental

Device Facts

• Record ID: K222636
• Device Name: ET Abutment System
• Applicant: Hiossen, Inc.
• Product Code: NHA · Dental
• Decision Date: Apr 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The ET Abutment System consists of various dental abutments (angled, cylinder, goldcast, multi, O-ring, etc.) designed to connect to ET Dental Implants. These components provide support for prosthetic restorations like crowns, bridges, and overdentures. The devices are manufactured from medical-grade titanium alloy (ASTM F136), CP titanium, or polymers (POM, NBR, Polycarbonate). They are supplied non-sterile and are intended for steam sterilization by the user. The system is used in a clinical dental setting by a dentist or dental professional. The abutments are placed onto the dental implant to serve as the interface for the final prosthesis. By providing a stable connection between the implant and the restoration, the system enables the functional and aesthetic replacement of missing teeth, benefiting patients by restoring oral function.

Clinical Evidence

No clinical performance data was submitted. Substantial equivalence is supported by non-clinical performance testing, including fatigue testing in accordance with ISO 14801 and MRI compatibility assessments based on scientific rationale and published literature.

Technological Characteristics

Materials: Titanium alloy (ASTM F136), CP Titanium, POM, NBR, Polycarbonate. Sensing/Actuation: None (mechanical interface). Energy Source: None. Connectivity: None. Sterilization: Moist heat (ISO 17665-1). Form factor: Various lengths/diameters for dental abutments.

Indications for Use

Indicated for partially or fully edentulous patients requiring prosthetic restoration support (crowns, bridges, overdentures) via 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

• Osstem Abutment System (K182091)

Reference Devices

• Osstem Implant System - Abutment (K161689)
• ET US SS Prosthetic System (K160670)
• Hiossen Prosthetic System (K140507)
• ET/SS Implant System (K120847)
• Prosthetic System (K110308)
• HS/HG Prosthetic System (K100245)
• HU/HS/HG Prosthetic System (K081575)
• US/SS/GS System (K073247)
• US System (K062030)

Submission Summary (Full Text)

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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.

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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) 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 ([e-mail]) or phone [phone] 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

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### 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)

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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:<br>Submitted by: | Hiossen, Inc.<br>85 Ben Fairless Drive<br>Fairless Hills, PA 19030 |
|-------------------------------------------------------------------|--------------------------------------------------------------------|
| Contact Person:<br>Telephone Number:<br>Fax Number: | Peter Lee<br>267-759-7031<br>267-759-7031 |
| Date Prepared: | April 28, 2023 |
| 6.2 Device Name:<br>• Proprietary Name:<br>• Classification Name: | ET Abutment System<br>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.

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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<br>ET Abutment System | Primary Predicate Devices<br>Osstem Abutment System |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. |
| 510(K) No. | New device | K182091 |
| Intended use | The ET Abutments are indicated for use<br>with ET Dental Implants to provide support<br>to prosthetic restoration such as crowns,<br>bridges and overdentures in partially or fully<br>edentulous patients. | Osstem Abutment System is intended for<br>use with a dental implant to provide support<br>for prosthetic restorations such as crowns,<br>bridges, or overdentures.<br>• Link Abutment for CEREC |
| | | The Link Abutment for CEREC is titanium<br>alloy abutments placed onto OSSTEM<br>dental implants to provide support for<br>customized prosthetic restorations. Link<br>Abutment for CEREC is indicated for screw-<br>retained single tooth or cement-retained<br>single tooth and bridge restorations. All<br>digitally designed copings and/or crowns for<br>use with the Link abutment for CEREC is to<br>be scanned using Sirona CEREC AC or<br>CEREC AF or CEREC AI, designed using<br>Sirona inLab software (Version 3.65) or<br>Sirona CEREC Software (Version 4.2) and<br>manufactured using a Sirona CEREC or<br>inLab MC X or MC XL milling unit. CAD/CAM<br>manufacturing/milling occurs at dental<br>laboratories per the design limitations of the<br>Sirona CEREC. |
| Sterilization | • Delivered non-sterilized<br>• Steam sterilized by user | • Delivered non-sterilized<br>• Steam sterilized by user |
| Packaging | • Housed in Tyvek-lidded blister tray<br>• Placed in a tamper-evident outer<br>package. | • Housed in Tyvek-lidded blister tray<br>• Placed in a tamper-evident outer<br>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) | $1.0~5.0$ | $1.0~5.0$ |
| 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…