(313 days)
The GSIII System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The GSIII System is for single and two stage surgical procedures. It is not for immediate load.
The GS III System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The GS III 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.
I am sorry but this document does not contain the information you are looking for. The document is a 510(k) summary for a dental implant system (GS III System) and discusses its substantial equivalence to predicate devices, safety tests, and indications for use. It does not include details on acceptance criteria or a study proving the device meets specific performance metrics in the way you've outlined with performance data, sample sizes, expert ground truth, or comparative effectiveness studies.
The document primarily focuses on regulatory submission requirements for substantial equivalence, not a detailed clinical or performance study with the requested metrics.
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#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea el: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
STEM Implant Co., Lt
510(k) Summary
MAR - 3 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: April 24, 2009
- Company and Correspondent making the submission:
- Submitter's Name :
OSSTEM Implant Co., Ltd.
- Address :
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea
- Contact :
Mr. JongHyuk Seo
GS III System
- Device :
Trade or (Proprietary) Name :
Common or usual name :
Classification Name :
Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE
- Predicate Device :
The HG III Fixture System, HIOSSEN Inc. K082213 The Ziocera & Convertible System, OSSTEM Implant Co., Ltd, K081786
- Description :
The GS III System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The GS III 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.
The GS III System is substantially equivalent in design, function and intended use to the HGIII Fixture System(K082213) of HIOSSEN Inc and Ziocera & Convertible System(K081786) of OSSTEM Implant Co., Ltd.
The HG/GS 3.5 mm fixtures are not intended to be used with HG Ziocera angled abutment
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
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Image /page/1/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in bold, sans-serif font on the top line. Below it, the word "IMPLANT" is in a smaller, sans-serif font. There is a degree symbol to the right of the word "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
5. Indication for use :
The GS III System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
The GS III System is for single and two stage surgical procedures. It is not for immediate load.
6. Review :
The GS III System has same material and indication for use and similar design and technological characteristics as the predicate device.
The GS III System 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. Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the GS III System is safe and effective and substantially equivalent to the predicate device as described herein.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Osstem Implants, Company Limited C/O Mr. Patrick Lim Manager Hiossen, Incorporated 85 Ben Fairless Hills Fairless, Pennsylvania 19030
MAR - 3 2010
Re: K091208
Trade/Device Name: GSIII System Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 1, 2010 Received: March 2, 2010
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.
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation
. Center for Devices and
Radiological Health
Enclosure
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OSSTEM°
IMPLANT
OS
507-
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) Number K 0912 08
Device Name: GSIII System
Indication for use : The GSIII System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgeworld. The GSIII System is for single and two stage surgical procedures. It is not for immediate load.
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)
RSBeetzDNS for Dr. K.L. mulay
Division Sign-Off) livision of Anesthesiology, General Hospital nfection Control, Dental Devices
10(k) Number: K091208
QS-QI-505-2(Rev.0)
Letter(8.5 X 11in)
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.