ET SMARTFIT ABUTMENT

K123627 · Hiossen, Inc. · NHA · Jun 28, 2013 · Dental

Device Facts

• Record ID: K123627
• Device Name: ET SMARTFIT ABUTMENT
• Applicant: Hiossen, Inc.
• Product Code: NHA · Dental
• Decision Date: Jun 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

ET SmartFit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Device Story

ET SmartFit Abutment is a titanium alloy (Ti-6Al-4V) dental abutment used to support prosthetic restorations like crowns, bridges, or overdentures. The device is customized using a CAD/CAM system based on a patient's mouth model to ensure proper fit. It is intended for use with dental implants (specifically the ETIII SA Fixture). The abutment features diameters ranging from 4mm to 15mm and angulations from 0° to 30°. It is used by dental professionals in a clinical setting. The manufacturing process involves CAD/CAM milling at the Hiossen factory. The device provides a stable connection between the endosseous implant and the final prosthesis, facilitating functional and aesthetic restoration for the patient.

Clinical Evidence

No clinical studies were submitted. Substantial equivalence is based on identical materials, manufacturing processes, chemical composition, intended use, and body contact compared to the predicate device (K110308). Bench testing, including fatigue testing per ISO 14801, was performed to demonstrate compliance with special controls for endosseous dental abutments.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V). Dimensions: 4mm-15mm diameter, 0°-30° angulation. Connection: Hex (2.1mm, 2.5mm) and Non-Hex ports. Manufacturing: CAD/CAM milling. Testing: Fatigue testing per ISO 14801. Biocompatibility: Compliant with international/US regulations.

Indications for Use

Indicated for patients requiring prosthetic restoration (crowns, bridges, or overdentures) supported by 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

• The Prosthetic System, Osstem Implant Co., Ltd. (K110308)

Reference Devices

• ETIII SA Fixture (K101096)

Submission Summary (Full Text)

{0}------------------------------------------------

K123627

Image /page/0/Picture/1 description: The image shows the word "HOSSEN" in a stylized font. The letters are outlined in black, with the interior of the letters appearing to be a darker shade. The "H" has a decorative flourish extending from the top.

JUN 2 8 2013

Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : [phone] / Fax : [phone] www.hiossen.com

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: February 28, 2012

1. Company and Correspondent making the submission:

- Submitter's Name :

- Address :

- Telephone No. :

- Contact :

2. Device :

Trade or (Proprietary) Name : Common or usual name :

Classification Name :

HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills PA 19030 888 678 0001 Mr. Patrick Lim

ET SmartFit Abutment Dental Device Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA

#### 3. Predicate Device :

K110308, The Prosthetic System, Osstem Implant Co., Ltd.

4. Description :

I ) The ET SmartFit Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. That is customized abutment considering shape of the finial prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing . All manufacturing processes of ET SmartFit abutment such as CAD/CAM manufacturing and milling are conducted in the Hiossen factory

\$

| range of diameters | Ø4 mm ~ Ø15mm |
|-------------------------------|--------------------|
| possible range of angulations | 0° ~ 30° |
| type of implant-abutment | Hex (2.1mm, 2.5mm) |
| connection ports | Non Hex |

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the word "HOSSEN" in a stylized font. The letters are filled with a pattern of diagonal lines, giving them a textured appearance. The overall design is simple but visually interesting due to the font and the patterned fill.

Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : [phone] / Fax : [phone] www.hiossen.com

2) The ET SmartFit Abutment is used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. Use only the basal screws provided for the Customized Abutment. The surgical procedure for Customized abutment is the same as the surgical procedure for the cement-retained abutments.

- 3) The ET SmartFit Abutment is the same with other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
4) The ET SmartFit Abutment is substantially equivalent in design, function and intended use to the Prosthetic System (K110308) of Osstem Implant Co., Ltd.

5) The ET SmartFit Abutment is used with ETIII SA Fixture (K101096)

| | ET SmartFit Abutment | Prosthetic System (Custom Abutment) |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | HIOSSEN Inc. | Osstem Implant Co., Ltd |
| 510(k)<br>Number | New | K110308 |
| Design | Image: ET SmartFit Abutment design | Image: Prosthetic System design |
| Intended use | ET SmartFit Abutment is<br>intended for use with a<br>dental implant to provide<br>support for prosthetic<br>restorations such as<br>crowns, bridges, or<br>overdentures. | Prosthetic System is<br>intended for use with a<br>dental implant to provide<br>support for prosthetic<br>restorations such as<br>crowns, bridges, or<br>overdentures. |
| Material | Titanium Alloy<br>(Ti-6Al-4V) | Titanium Alloy<br>(Ti-6AI-4V) |

# - Substantial Equivalence Matrix

5. Indication for use :

ET SmartFit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

QS-QI-505-3(Rev.0)

Letter(8.5 X 11in)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the word "HOSSEN" in a stylized font. The letters are outlined in black and filled with a textured pattern. The "H" has an extended flourish at the top.

Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : [phone] / Fax : [phone] www.hiossen.com

#### 6. Review :

ET SmartFit Abutment has the same material, indication for use, design and technological characteristics as the predicate device.

ET SmartFit Abutment has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable international and US regulations.

7. Summary of nonclinical testing

The Fatigue testing for ET SmartFit Abutment was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 Dentistry -Fatigue test for endosseous dental implants with the worst case scenario. The results are in compliance with it and were similar to previously cleared predicate devices."

#### 8. Summary of clinical testing

No clinical studies are submitted because the ET SmartFit Abutment has the same materials, manufacturing process, chemical composition, indication for use and body contact as Prosthetic System (K110308).

Additionally, we certify that ET SmartFit Abutment is not processed that length of post is under 4mm and angulations is under 30°

### 9. Conclusions

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 that the ET SmartFit Abutment is substantially equivalent to the predicate devices as described herein

QS-Q1-505-3(Rev.0)

Letter(8.5 X 11in)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is rendered in black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

.

June 28, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Patrick Lim Manager HIOSSEN. Incorporated 85 Ben Fairless Drive FAIRLESS HILLS PA 19030

Re: K123627

Trade/Device Name: ET SMARTFit Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 29, 2013 Received: June 5, 2013

Dear Mr. Lim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{4}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Kwame O. Ulmer -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "HIOSSEN" in a bold, sans-serif font. The "H" and "I" are connected, and there is a curved line above the "O". The letters are all capitalized and in black, set against a white background.

Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : [phone] / Fax : [phone] www.hiossen.com

K 123627 510(k) Number K _

Device Name : ET SMARTfit Abutment

Indication for use : ET SMARTfit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Prescription Use X (Per 21CFR801 Subpart D)

Over-The-Counter Use OR (Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDBD)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green -5
2013.06.28 09:27:33 -04100

for Susan Runner, DDS, MA

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesi Devices Division of Antaliastonogram

123627

**510(k) Number:**

QS-QI-505-2(Rev.0)

Letter(8.5 X 11in)

- 1 -