(267 days)
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No
The document describes a dental implant system made of titanium and focuses on its material, shape, surface treatment, and intended use. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is a dental implant system intended to be surgically placed in the bone of the jaw to support restorations, which is a therapeutic intervention.
No
Explanation: The provided text describes a dental implant system (GS System) used for restoring teeth in edentulous mandibles and maxillae. Its intended purpose is structural support for dental restorations, and there is no mention of it being used to diagnose diseases or conditions.
No
The device description explicitly states it is a dental implant system made of titanium metal intended for surgical placement, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The GS System is described as a dental implant system made of titanium metal intended to be surgically placed in the bone of the jaw. This is a surgically implanted device, not a test performed on a sample outside the body.
- Intended Use: The intended use is to support dental restorations in edentulous mandibles and maxillae. This is a structural and functional purpose within the body, not a diagnostic test.
Therefore, the GS System falls under the category of a medical device, specifically a dental implant, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GS 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 internediate abutment support for fixed bridgework. GS System is for one stage surgical procedures. It is not intended for immediate load.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The GS System is a dental implant system made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The GS 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 the SS System is R.B.M. (Resorbable Blasting Media) and that of GS system is R.B.M. or CellNest.
The GS System is substantially equivalent in design, function and intended use to the SS 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
Not Found
Intended User / Care Setting
Not Found
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)
The GS 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
K06 3861
510(k) Summary
SEP 2 1 2007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: December 4, 2006
- 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. Seung Woo Song |
-
- Device:
| Proprietary Name: | GS System |
|---|---|
| Common Name -: | Dental Implant System |
| Classification Name: | Endosseous dental implant |
| 21CFR 872.3640 and 872.3630 | |
| Class II | |
| DZE, NHA |
-
- Predicate Device:
SS System, Osstem Co., Ltd, K062051
- Predicate Device:
-
- Description:
The GS System is a dental implant system made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
- Description:
The GS 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 the SS System is R.B.M. (Resorbable Blasting Media) and that of GS system is R.B.M. or CellNest.
The GS System is substantially equivalent in design, function and intended use to the SS System of Osstem Implant Co., Ltd.
Osstem Co., Ltd
510(k) Summary Page 1 of 2
1
K06 3861
5. Indication for use:
GS 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 internediate abutment support for fixed bridgework. GS System is for one stage surgical procedures. It is not intended for immediate load.
6. Review:
The GS System has similar material, indication for use, design and technological characteristics as the predicate device.
The GS 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. Conclusions:
Based on the information provided in this premarket notification Osstem concludes that the GS System is safe and effective and substantially equivalent to the predicate device as described herein.
2
Image /page/2/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 stripes forming its wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Osstem Implant Company, Limited C/O Ms. Cathryn N. Cambria Consultant Cambria Regulatory Consulting, Incorporated 5536 Trowbridge Drive Dunwoody, Georgia 30338
Re: K063861
Trade/Device Name: GS System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 29, 2007 Received: September 4, 2007
Dear Ms. Cambria:
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.
SEP 2 1 2007
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.
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Page 2 - Ms. Cambria
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 yours,
Syptie Y. Michaud MD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number K 06 3861
Device Name: GS System
GS System is intended for use in partially or fully edentulous Indication for use: 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 System is for one stage surgical procedures. It is not for immediate load.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR (Per 21CFR801 Subpart D)
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 Runner
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K063861
Osstem Implant Co., Ltd
Indication for Use Page 1 of 1