(26 days)
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No
The summary describes a standard dental implant system made of titanium, with no mention of AI or ML technology in its intended use, device description, or performance studies.
No
The device, a dental implant, is intended for supporting restorations and fixed bridgework in the jaw, and while it aids in the restoration of function, its primary role is structural support rather than directly treating or curing a disease or condition. It is a prosthetic device.
No
The device description clearly states it is a "dental implant made of titanium metal intended to be surgically placed in the bone." Its intended use is to support single or multiple-unit restorations. This indicates it is a therapeutic or reconstructive device, not one used for diagnosis.
No
The device description explicitly states it is a dental implant made of titanium metal, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the GS Fixture System is a "dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches." This is a surgically implanted device, not a device used for testing samples outside the body.
- Intended Use: The intended use describes its function as a support for dental restorations in the mouth, not for diagnostic testing.
Therefore, based on the provided information, the GS Fixture System is a surgical dental implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
GS Fixture 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. GS Fixture System is for one and two stage surgical Procedures. It is not for immediate load.
Product codes
DZE
Device Description
The GS Fixture 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 Fixture 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 differences between them are shape. The surface treatment of GS Fixture System is of R.B.M (Resorbable Blasting Media).
The GS Fixture System is substantially equivalent in design, function and intended use to the GS System of Osstem Implant Co., Ltd.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mandibles and maxillae
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo features a stylized circular design with the word "osstem" below it. The text provides the company's address as #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea, along with their telephone number +82 51 850-2500, fax number +82 51 850-4341, and website www.osstem.com.
510(k) Summary
KO72896
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: September 29, 2007
- Company and Correspondent making the submission:
NOV 0 6 2007
- Submitter's Name :
- Address :
OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea
-
Contact :
Mr. JongHyuk Seo -
- Device :
Trade or (Proprietary) Name : Common or usual name : Classification Name :
- Device :
GS Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE
-
- Predicate Device :
GS System, Osstem Implant Co., Ltd, (K063861)
- Predicate Device :
-
- Description :
The GS Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
- Description :
The GS Fixture 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 differences between them are shape. The surface treatment of GS Fixture System is of R.B.M (Resorbable Blasting Media).
The GS Fixture System is substantially equivalent in design, function and intended use to the GS System of Osstem Implant Co., Ltd.
1
Image /page/1/Picture/0 description: The image shows a logo with the word "osstem" in a sans-serif font at the bottom. Above the text is a circular graphic that appears to be two overlapping or intersecting shapes, possibly representing a stylized "O". The logo is black and white.
5. Indication for use :
GS Fixture 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. GS Fixture System is for one and two stage surgical Procedures. It is not for immediate load.
6. Review :
GS Fixture System has similar material, indication for use, design and technological characteristics as the predicate device.
GS Fixture 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 Fixture System is safe and effective and substantially equivalent to the predicate device as described herein
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OSSTEM Implant Company, Limited C/O Mr. Kim Min Joo Manager OSSTEM. Incorporated One Ben Fairless Drive Fairless Hills, Pennsylvania 19030
NOV 0 6 2007
Re: K072896
Trade/Device Name: GS Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 29, 2007 Received: October 11, 2007
Dear Mr. Joo:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Joo
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Neil R.b. Dyl
Chiu Lin, Ph.D. for
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a logo with a circular design above the word "osstem". The circular design consists of two overlapping circles, creating a sense of connection or unity. The word "osstem" is written in a simple, sans-serif font, with all letters in lowercase. The logo appears to be for a company or organization named Osstem.
510(k) Number K _
Device Name: GS Fixture System
Indication for use: GS fixture 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. GS fixture 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)
Susan Rumore
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Y0572896
QS-Q1-505-2(Rev.0)
A4(210X297)mm