(304 days)
No
The 510(k) summary describes a mechanical dental prosthetic system made of titanium and titanium alloy. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The performance studies focus on mechanical fatigue testing.
No
The device is described as a prosthetic system that provides support for prosthetic restorations, not a therapeutic device. Its function is to aid in restoration, not to treat or cure a disease or condition.
No
The device is described as aiding in prosthetic restoration and focuses on mechanical support rather than diagnosis.
No
The device description explicitly states it is made of titanium and titanium alloy and consists of physical components (Abutments and Abutment Screws).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic restorations in the mouth, which is a clinical application, not an in vitro diagnostic test.
- Device Description: The device is a physical component (abutments and screws) made of titanium, designed to be implanted and used mechanically. It does not involve analyzing biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is a dental prosthetic component used in a surgical and restorative procedure.
N/A
Intended Use / Indications for Use
ET Prosthetic System 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 Prosthetic System is device made of titanium and titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. It's surfaces are partially TiN coated and uncoated.
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 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.
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.)
0
JAN 1 0 2014
OSSTEM Implant Co., Ltd #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.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 26, 2013
- Company and Correspondent making the submission:
- Submitter's Name :
- Address :
- Contact :
- Phone:
- Correspondent's Name:
- Address:
- Contact:
- Phone:
- Device :
Trade or (Proprietary) Name : Common or usual name :
Classification Name :
ET Prosthetic System Dental Abutment Endosseous dental implant abutment 21CFR872.3630 Class II NHA
OSSTEM Implant Co., Ltd.
Mr. Hee Kwon Son
+82 51 850 2575
HIOSSEN Inc.
Patrick Lim 888 678 000 I
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea
85 Ben Fairless Dr. Fairless Hills, PA 19030
-
- Description:
-
- The ET Prosthetic System is device made of titanium and titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. It's surfaces are partially TiN coated and uncoated.
-
- The ET Prosthetic System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
QS-Q1-505-3(Rev.0)
Letter(8.5 X 11in)
1
OSSTEM®
OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
-
- These proposed abutments are compatible with the HIOSSEN Implant fixture only. HTIII SA Fixture (K101096)
- Substantial Equivalence Matrix
| ET Prosthetic System | ET/SS Implant System | |
|---|---|---|
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd |
| 510(k) Number | New | K120847 |
| Design | Image: Rigid / Transfer Abutment | Image: Rigid / Transfer Abutment |
| Rigid / Transfer Abutment | Rigid / Transfer Abutment | |
| Design | Image: FreeForm ST Abutment | Image: FreeForm ST Abutment |
| FreeForm ST Abutment | FreeForm ST Abutment | |
| Intended use | ET Prosthetic System is intended | |
| for use with a dental implant to | ||
| provide support for prosthetic | ||
| restorations such as crowns, bridges, | ||
| or overdentures. | Intended for use as an aid in | |
| prosthetic rehabilitation. | ||
| Material | Titanium Alloy | |
| Ti 6Al 4V (ASTM F136) | Titanium Alloy | |
| Ti 6Al 4V (ASTM F136) | ||
| SE | - Rigid / Transfer Abutment: | |
| No changes in function and intended use. Fully the same except G/H | ||
| Shape. |
- FreeForm ST Abutment:
No changes in function and intended use Fully the same.
Art# of diameter 5.0 mm type us added . | |
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
2
OSTEM®
THEM Implant Co., I
507-8 Geoje3-Dong Yeonie-Gu Busan. 611-804 Republic of K Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Part Name | Multi Abutment | Convertible
Abutment | Multi Angled
Abutment |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------------------------|
| 510K | New | K120847 | K110308 |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Design | Image: Multi Abutment Design | Image: Convertible Abutment Design | Image: Multi Angled Abutment Design |
| Type | One body | One body | Two piece
(Abutment + Screw) |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Compatible
Fixture | HTIII SA Fixture
(K101096). | HTIII SA Fixture
(K101096). | HTIII SA Fixture
(K101096). |
| Upper
Connection
Compatible
Device | US Esthetic low
Cylinders | Convertible Cylinders | US Esthetic low
Cylinders |
| SE | No changes in function and intended use from the predicate device, convertible abutment_K120847.
Upper connection part is changed to use cylinder that is used with the
predicate device, multi angled abutment_K110308. | | |
5. Indication for use :
ET Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
6. Review :
ET Prosthetic System has same material and indication for use and similar design and technological characteristics as the predicate device.
Safety tests including biocompatibility have been considered to ensure the devices comply with the applicable International and US regulations.
-
- Summary of nonclinical testing
The Fatigue testing 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."
- Summary of nonclinical testing
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
3
OSSTEM Implant Co., Ltd. OSSTEM® #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
-
- Summary of clinical testing
No clinical studies are submitted
- Summary of clinical testing
-
- 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 Osstem Implant Co., Ltd. concludes that the ET Prosthetic System is substantially equivalent to the predicate devices as described herein
- Conclusions
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
- 4/4 -
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2014
OSSTEM Implant Company, Limited C/O Mr. Patrick Lim Manager HiOSSEN Incorporated 85 Ben Fairless Drive Fairless Hills, PA 19030
Re: K130662
Trade/Device Name: ET Prosthetic System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 29, 2013 Received: December 4, 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. Iisting 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.
5
Page 2 - Mr. Lim
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 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/ReportalProblem/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
Sincerely yours,
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
FOR
Erin I. Keith. M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
OSSTEM Implant Co.,
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
Indications for Use
510(k) Number K _130662
Device Name : ET Prosthetic System
Indication for use : ET Prosthetic System 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) OR Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marys. Runner -S
2074.01.09
18.462-05'00'
Susan R
QS-QI-505-2(Rev.0)
Letter(8.5 X 1 I I in)
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