(217 days)
No
The description focuses on CAD/CAM manufacturing and standard fatigue testing, with no mention of AI or ML algorithms for design, analysis, or performance prediction.
No.
The device is an abutment for prosthetic restorations, not a therapeutic device designed to treat a disease or condition.
No
The device description indicates that the ET SmartFit Abutment is a titanium alloy device intended for prosthetic restoration to support crowns, bridges, or overdentures. Its purpose is to provide structural support for prosthetics, not to diagnose a medical condition.
No
The device description explicitly states the device is made of titanium alloy and is a physical abutment used with dental implants. It describes manufacturing processes like CAD/CAM and milling, which are hardware-related.
Based on the provided information, the ET SmartFit Abutment is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic restorations (crowns, bridges, overdentures) used with a dental implant. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The description focuses on the material (titanium alloy), manufacturing process (CAD/CAM), and how it's used in a prosthetic restoration. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The ET SmartFit Abutment is a medical device used in a dental procedure for prosthetic restoration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications 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.
Product codes
NHA
Device Description
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
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.
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.
The ET SmartFit Abutment is substantially equivalent in design, function and intended use to the Prosthetic System (K110308) of Osstem Implant Co., Ltd.
The ET SmartFit Abutment is used with ETIII SA Fixture (K101096).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
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).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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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 : 1-888-678-0001 / Fax : 1-267-759-7004 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
- Company and Correspondent making the submission:
-
Submitter's Name :
-
Address :
-
Telephone No. :
-
Contact :
- 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.
- 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 : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
- 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.
-
- 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.
-
The ET SmartFit Abutment is substantially equivalent in design, function and intended use to the Prosthetic System (K110308) of Osstem Implant Co., Ltd.
-
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) | ||
| Number | New | K110308 |
| Design | Image: ET SmartFit Abutment design | Image: Prosthetic System design |
| 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. | Prosthetic System is | |
| intended for use with a | ||
| dental implant to provide | ||
| support for prosthetic | ||
| restorations such as | ||
| crowns, bridges, or | ||
| overdentures. | ||
| Material | Titanium Alloy | |
| (Ti-6Al-4V) | Titanium Alloy | |
| (Ti-6AI-4V) |
- Substantial Equivalence Matrix
- 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 : 1-888-678-0001 / Fax : 1-267-759-7004 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.
- 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 (800) 638-2041 or (301) 796-7100 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 : 1-888-678-0001 / Fax : 1-267-759-7004 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)
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