← Product Code [NHA](/productcode/NHA) · K253372

# ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments (K253372)

_Hiossen, Inc. · NHA · May 14, 2026 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253372

## Device Facts

- **Applicant:** Hiossen, Inc.
- **Product Code:** [NHA](/productcode/NHA.md)
- **Decision Date:** May 14, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3630
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Indications for Use

ET Healing Abutments, ET Scan Healing Abutments and EK Scan Healing Abutments are temporary abutments used to make a natural soft tissue shape until setting up prosthesis.

## Device Story

Temporary dental abutments; used during healing phase following implant placement; guide/contour peri-implant soft tissue; create optimal emergence profile for final prosthesis. ET/EK Scan variants include integrated scan body functionality; unique upper surface geometry captured by intraoral scanners for digital impression workflows; eliminates need to remove healing abutment for scanning. Used in dental clinics; operated by dentists/prosthodontists. Output is physical soft tissue shape and digital scan data for CAD/CAM prosthetic design. Benefits include reduced clinical steps, improved soft tissue healing, and accurate digital prosthetic planning.

## Clinical Evidence

No clinical data submitted. Substantial equivalence established via bench testing, material characterization, and validation of sterilization (ISO 11137) and packaging (ISO 11607-1) consistent with predicate devices.

## Technological Characteristics

Materials: Titanium Grade 4 (ASTM F67) for abutments, Titanium Alloy (ASTM F136) for screws. Form factor: Various diameters (4.3-7.3mm) and lengths. Sterilization: Gamma irradiation. Connectivity: Passive (scan body geometry for optical intraoral scanning).

## Regulatory 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

- Hiossen Implant System ([K140934](/device/K140934.md))
- EK Healing Abutment ([K203360](/device/K203360.md))

## Reference Devices

- TS Abutment System ([K233194](/device/K233194.md))
- Osstem Implant System ([K222778](/device/K222778.md))

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 14, 2026

Hiossen Inc
Simyung Park
Regulatory Affairs Specialist
85 Ben Fairless Drive
Fairless Hills, Pennsylvania 19030

Re: K253372
Trade/Device Name: ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA
Dated: April 22, 2026
Received: April 22, 2026

Dear Mateusz Leszczak:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253372 - Mateusz Leszczak
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K253372 - Mateusz Leszczak
Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF

|  DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.  |
| --- | --- |
|  510(k) Number (if known) K253372  |   |
|  Device Name ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments  |   |
|  Indications for Use (Describe) ET Healing Abutments, ET Scan Healing Abutments and EK Scan Healing Abutments are temporary abutments used to make a natural soft tissue shape until setting up prosthesis.  |   |
|  Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)  |   |
|  CONTINUE ON A SEPARATE PAGE IF NEEDED.  |   |
|  This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*  |   |
|  The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov  |   |
|  "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."  |   |

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HIOSSSEN

IMPLANT

85 Ben Fairless Drive

Fairless Hills, PA, USA 19030

# Traditional 510(K) Summary

Submitter Information:

Submitted by: Hiossen, Inc.
85 Ben Fairless Drive
Fairless Hills, PA 19030

Primary Contact: Simyung Park
Regulatory Affairs Specialist
Email address: : simyung.park@hiossen.com

Secondary Contact: Haewon Park, Ph.D.
Manager, Regulatory Affairs
Email address: haewon.park@hiossen.com

Date Prepared: May 11, 2026

Device Information:

- Proprietary Name: ET Healing Abutment; ET Scan Healing Abutment; EK Scan Healing Abutment
- Classification Name: Endosseous dental implant abutment
- CFR Number: 872.3630
- Device Class: Class II
- Product Code: NHA

Predicate Devices:

|  Primary Predicate Device | 510(k) | Manufacturer(s)  |
| --- | --- | --- |
|  Hiossen Implant System | K140934 | Hiossen, Inc.  |
|  Reference Device | 510(k) | Manufacturer(s)  |
|  TS Abutment System | K233194 | Osstem Implant Co., Ltd.  |
|  Osstem Implant System | K222778 | Osstem Implant Co, Ltd.  |
|  EK Dental Implants and Abutments | K203360 | Hiossen, Inc.  |

Description of Device:

The ET Healing abutment is a temporary abutment designed for use in combination with the ET dental implant system during the healing phase following implant placement. Its primary purpose is to guide and contour the peri-implant soft tissue to create an optimal emergence profile for the final prosthetic restoration.

The ET Scan Healing abutment is designed for compatibility with Hiossen's ET Dental Implant System and combines the functionality of a healing abutment and a scan body, allowing for digital impressions to

ET Healing, ET Scan Healing, EK Scan Healing Abutments Traditional 510(k)
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HIOSSSEN

IMPLANT

85 Ben Fairless Drive

Fairless Hills, PA, USA 19030

be taken without removing the healing abutment. The Scan Healing Abutment features a unique shape on its upper surface which is captured through the use of an intraoral scanner to aid in identification within CAD programs. ET Scan Healing Abutments are available in various lengths and widths as presented within this submission.

The EK Scan Healing abutment is designed for compatibility with Hiossen's EK Dental Implant System and combines the functionality of a healing abutment and a scan body, allowing for digital impressions to be taken without removing the healing abutment. The Scan Healing Abutment features a unique shape on its upper surface which is captured through the use of an intraoral scanner to aid in identification within CAD programs. EK Scan Healing Abutments are available in various lengths and widths as presented within this submission.

ET Healing Abutment

|  Cross-Sectional View of Implant and Healing Abutment Assembly |   |   |   |
| --- | --- | --- | --- |
|  ET Healing Abutment Type | Diameter (D, mm) | Length (L, mm) | Product Code  |
|  Mini (Anodized Yellow) | 4.3 | 6.0 | ETHLA4006 M  |
|   |   |  9.0 | ETHLA4009 M  |
|   |  4.8 | 6.0 | ETHLA4506 M  |
|   |   |  9.0 | ETHLA4509 M  |
|  Regular | 4.3 | 6.0 | ETHLA4006 R  |
|   |   |  9.0 | ETHLA4009 R  |
|   |  4.8 | 6.0 | ETHLA4506 R  |
|   |   |  9.0 | ETHLA4509 R  |
|   |  5.3 | 6.0 | ETHLA5006 R  |

ET Healing, ET Scan Healing, EK Scan Healing Abutments Traditional 510(k)

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HIOSSSEN

IMPLANT

85 Ben Fairless Drive

Fairless Hills, PA, USA 19030

|   |  | 9.0 | ETHLA5009 R  |
| --- | --- | --- | --- |
|   |  6.3 | 6.0 | ETHLA6006 R  |
|   |   |  9.0 | ETHLA6009 R  |
|   |  7.3 | 6.0 | ETHLA7006 R  |
|   |   |  9.0 | ETHLA7009 R  |

ET Scan Healing Abutment

|  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
|  No | Code | D (Ø) | L(mm) | Hex (mm) | Remark  |
|  1 | ETSHA404MB | 4.3 | 6.6 | 2.08 | Mini  |
|  2 | ETSHA405MB | 4.3 | 7.6 | 2.08 | Mini  |
|  3 | ETSHA407MB | 4.3 | 9.6 | 2.08 | Mini  |
|  4 | ETSHA409MB | 4.3 | 11.6 | 2.08 | Mini  |
|  5 | ETSHA454MB | 4.8 | 6.6 | 2.08 | Mini  |
|  6 | ETSHA455MB | 4.8 | 7.6 | 2.08 | Mini  |
|  7 | ETSHA457MB | 4.8 | 9.6 | 2.08 | Mini  |
|  8 | ETSHA459MB | 4.8 | 11.6 | 2.08 | Mini  |
|  9 | ETSHA404RB | 4.3 | 6.5 | 2.48 | Regular  |

ET Healing, ET Scan Healing, EK Scan Healing Abutments Traditional 510(k)

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HIOSSSEN

IMPLANT

85 Ben Fairless Drive

Fairless Hills, PA, USA 19030

|  10 | ETSHA405RB | 4.3 | 7.5 | 2.48 | Regular  |
| --- | --- | --- | --- | --- | --- |
|  11 | ETSHA407RB | 4.3 | 9.5 | 2.48 | Regular  |
|  12 | ETSHA409RB | 4.3 | 11.5 | 2.48 | Regular  |
|  13 | ETSHA454RB | 4.8 | 6.5 | 2.48 | Regular  |
|  14 | ETSHA455RB | 4.8 | 7.5 | 2.48 | Regular  |
|  15 | ETSHA457RB | 4.8 | 9.5 | 2.48 | Regular  |
|  16 | ETSHA459RB | 4.8 | 11.5 | 2.48 | Regular  |
|  17 | ETSHA504RB | 5.3 | 6.5 | 2.48 | Regular  |
|  18 | ETSHA505RB | 5.3 | 7.5 | 2.48 | Regular  |
|  19 | ETSHA507RB | 5.3 | 9.5 | 2.48 | Regular  |
|  20 | ETSHA509RB | 5.3 | 11.5 | 2.48 | Regular  |
|  21 | ETSHA604RB | 6.3 | 6.5 | 2.48 | Regular  |
|  22 | ETSHA605RB | 6.3 | 7.5 | 2.48 | Regular  |
|  23 | ETSHA607RB | 6.3 | 9.5 | 2.48 | Regular  |
|  24 | ETSHA609RB | 6.3 | 11.5 | 2.48 | Regular  |
|  25 | ETSHA704RB | 7.3 | 6.5 | 2.48 | Regular  |
|  26 | ETSHA705RB | 7.3 | 7.5 | 2.48 | Regular  |
|  27 | ETSHA707RB | 7.3 | 9.5 | 2.48 | Regular  |

ET Scan Healing Abutment Screw

|   |   | B  |   |
| --- | --- | --- | --- |
|  Code | A (Ø) | B (mm) | Remark  |
|  ETSHASM04 | 2.2 | 11.0 | Mini  |

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HIOSSSEN

IMPLANT

85 Ben Fairless Drive

Fairless Hills, PA, USA 19030

|  ETSHASM05 | 2.2 | 12.0 | Mini  |
| --- | --- | --- | --- |
|  ETSHASM07 | 2.2 | 14.0 | Mini  |
|  ETSHASM09 | 2.2 | 16.0 | Mini  |
|  ETSHASR04 | 2.3 | 9.0 | Regular  |
|  ETSHASR05 | 2.3 | 10.0 | Regular  |
|  ETSHASR07 | 2.3 | 12.0 | Regular  |
|  ETSHASR09 | 2.3 | 14.0 | Regular  |

EK Scan Healing Abutment

|  |   |   |   |
| --- | --- | --- | --- |
|  Code | D (Ø) | L(mm) | Hex (mm)  |
|  EKSHA404B | 4.3 | 7.8 | 2.08  |
|  EKSHA405B | 4.3 | 8.8 | 2.08  |
|  EKSHA407B | 4.3 | 10.8 | 2.08  |
|  EKSHA409B | 4.3 | 12.8 | 2.08  |
|  EKSHA454B | 4.8 | 7.8 | 2.08  |
|  EKSHA455B | 4.8 | 8.8 | 2.08  |
|  EKSHA457B | 4.8 | 10.8 | 2.08  |
|  EKSHA459B | 4.8 | 12.8 | 2.08  |
|  EKSHA504B | 5.3 | 7.8 | 2.08  |
|  EKSHA505B | 5.3 | 8.8 | 2.08  |
|  EKSHA507B | 5.3 | 10.8 | 2.08  |
|  EKSHA509B | 5.3 | 12.8 | 2.08  |
|  EKSHA604B | 6.3 | 7.8 | 2.08  |
|  EKSHA605B | 6.3 | 8.8 | 2.08  |

ET Healing, ET Scan Healing, EK Scan Healing Abutments Traditional 510(k)

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HIOSSEN

IMPLANT

85 Ben Fairless Drive

Fairless Hills, PA, USA 19030

EK SHA 607B | 6.3 | 10.8 | 2.08
---|---|---|---
EKSHA609B | 6.3 | 12.8 | 2.08

# EK Scan Healing Abutment Screw

|  |   |
| --- | --- |
|  Code | A (Ø)  |
|  EKSHAS04 | 2.1  |
|  EKSHAS05 | 2.1  |
|  EKSHAS07 | 2.1  |
|  EKSHAS09 | 2.1  |

## Indications for Use:

ET Healing Abutments, ET Scan Healing Abutments and EK Scan Healing Abutments are temporary abutments used to make a natural soft tissue shape until setting up prosthesis.

## Substantial Equivalence:

|   | Subject Device | Primary Predicate Device | Reference Device  |
| --- | --- | --- | --- |
|   | ET Healing Abutment | Hiossen Implant System | TS Abutment System  |
|  510(k) Number | K253372 | K140934 | K233194  |
|  Manufacturer | Hiossen Inc. | Hiossen Inc. | Osstem Implant Co. Ltd.  |
|  Design |  |  |   |
|  Indications for Use | Used to make a natural soft tissue shape until setting up prosthesis. | Used to make a natural soft tissue shape until setting up prosthesis | Used to make a natural soft tissue shape until setting up prosthesis  |
|  Diameter mm (D) | 4.3 ~ 7.3mm | 4.3 ~ 7.3mm | 4.3 ~ 8.3mm  |
|  Length mm (L) | 6mm, 9mm | 7.5 ~ 12.5mm | 3 ~ 9mm  |

ET Healing, ET Scan Healing, EK Scan Healing Abutments Traditional 510(k)

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HIOSSSEN

IMPLANT

85 Ben Fairless Drive

Fairless Hills, PA, USA 19030

|  Material | Titanium Grade 4 (ASTMF67) | Titanium Grade 4 (ASTMF67) | Titanium Grade 4 (ASTMF67)  |
| --- | --- | --- | --- |
|  Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation  |
|  Shelf Life | 8 Years | 8 Years | 8 Years  |

|   | Subject Device | Primary Predicate Device | Reference Device  |
| --- | --- | --- | --- |
|   | ET Scan Healing Abutment | ET Healing Abutment | TS Scan Healing Abutment  |
|  510(k) Number | K253372 | K140934 | K222778  |
|  Manufacturer | Hiossen Inc. | Hiossen Inc. | Osstem Implant Co. Ltd.  |
|  Design |  |  |   |
|  Indications for Use | Used to make a natural soft tissue shape until setting up prosthesis. | Used to make a natural soft tissue shape until setting up prosthesis | Used to make a natural soft tissue shape until setting up prosthesis  |
|  Diameter mm (D) | 4.3 ~ 7.3mm | 4.3 ~ 7.3mm | 4.3 ~ 7.3mm  |
|  Length mm (L) | 6.5 ~ 11.6mm Screw: 9.0 ~16.0mm | 7.5 ~ 12.5mm | 5.5 ~ 11.6mm Screw: 8.0 ~16.0mm  |
|  Material | Titanium Grade 4 (ASTMF67) Screw: Titanium Alloy (ASTM F136) | Titanium Grade 4 (ASTMF67) | Titanium Grade 4 (ASTMF67) Screw: Titanium Alloy (ASTM F136)  |
|  Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation  |
|  Shelf Life | 8 Years | 8 Years | 8 Years  |

|   | Subject Device | Primary Predicate Device | Reference Device  |
| --- | --- | --- | --- |
|   | EK Scan Healing Abutment | EK Healing Abutment | TS Scan Healing Abutment  |
|  510(k) Number | K253372 | K203360 | K222778  |
|  Manufacturer | Hiossen Inc. | Hiossen Inc. | Osstem Implant Co. Ltd.  |
|  Design |  |  |   |
|  Indications for Use | Used to make a natural soft tissue shape until setting up prosthesis. | Used to make a natural soft tissue shape until setting up prosthesis | Used to make a natural soft tissue shape until setting up prosthesis  |
|  Diameter mm (D) | 4.3 ~ 6.3mm | 4.0 ~ 8.0mm | 4.3 ~ 7.3mm  |
|  Length mm (L) | 7.8 ~ 12.8mm Screw: 9.5~14.5mm | 3.0 ~ 7.0mm | 5.5 ~ 11.6mm Screw: 8.0 ~16.0mm  |
|  Material | Titanium Grade 4 (ASTMF67) | Titanium Grade 4 (ASTMF67) | Titanium Grade 4 (ASTMF67)  |

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HIOSSSEN

IMPLANT

85 Ben Fairless Drive

Fairless Hills, PA, USA 19030

|   | Screw: Titanium Alloy (ASTM F136) |  | Screw: Titanium Alloy (ASTM F136)  |
| --- | --- | --- | --- |
|  Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation  |
|  Shelf Life | 8 Years | 8 Years | 8 Years  |

The information and data provided in this submission established the ET Healing Abutments, ET Scan Healing Abutments and EK Scan Healing Abutments presented in this submission are substantially equivalent to the predicate devices based on the intended use, materials, dimensions, and methods of sterilization.

## Non-Clinical Performance Data

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:

## Biocompatibility Testing

The ET Healing Abutments, ET Scan Healing Abutments and EK Scan Healing Abutments presented in this submission are manufactured using the same manufacturing process and same well known and well-established material as the predicate devices; therefore, we reason it was not necessary to re-test biocompatibility in order to support the biological safety of the subject devices. Furthermore, as described in International Standard Organization (ISO) standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing when a new material is used that has not been identified in a primary predicate device. The proposed devices are manufactured from standard raw material that are used in the primary predicate devices and other currently marketed dental implant and abutment system. Therefore, no additional biocompatibility testing is required to establish substantial equivalence.

## Sterilization Validation

The ET Healing Abutments and ET Scan Healing Abutments are gamma irradiated under the same conditions and process as the predicate device, the Hiossen Implant System (K140934) and validated following ISO 11137 [2006] Sterilization of health care products – Requirements for Validation and Routine control – Radiation Sterilization guidelines, therefore we reason it was not necessary to re-test validation in order to support the sterilization validity of the ET healing and scan healing abutments and includes acceptance of prior LAL endotoxin testing information from prior clearance.

The EK Scan Healing Abutments are gamma irradiated under the same conditions and process as the predicate device, the EK Healing Abutment (K203360) and validated following ISO 11137 [2006] Sterilization of health care products – Requirements for Validation and Routine control – Radiation Sterilization guidelines, therefore we reason it was not necessary to re-test validation in order to support the sterilization validity of the EK Scan Healing Abutments and includes acceptance of prior LAL endotoxin testing information from prior clearance.

## Shelf Life

The ET Healing Abutment, ET Scan Healing Abutment and EK Scan Healing Abutment shelf life are identical to their respective predicate devices HIOSSEN Implant System (K140934) and EK Dental Implants and Abutments (K203360) which have been validated for eight (8) years following ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems. The EK Dental Implants utilizes the exact same packaging materials & methods and is a medical grade titanium, non-mechanical, non-active device, therefore, degradation in performance characteristics is not likely over the established shelf life period. Therefore, no shelf-life re-validation or accelerated aging re-testing was performed

ET Healing, ET Scan Healing, EK Scan Healing Abutments Traditional 510(k)

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HIOSSEN IMPLANT

85 Ben Fairless Drive
Fairless Hills, PA, USA 19030

## Clinical Performance Testing

No clinical performance report(s) is being submitted.

## 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 Healing Abutments, ET Scan Healing Abutments and EK Scan Healing Abutments have the same design, intended use, structure, diameters, lengths, material surface, sterilization and packaging as the predicate devices listed in this submission and are substantially equivalent. The subject devices do not pose any new or increased risk as compared to both the legally marketed predicate and reference devices.

ET Healing, ET Scan Healing, EK Scan Healing Abutments Traditional 510(k) CONFIDENTIAL

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**Source:** [https://fda.innolitics.com/device/K253372](https://fda.innolitics.com/device/K253372)

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