(119 days)
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No
The document describes a dental implant and its intended use, with no mention of AI or ML technology.
No
The device is a dental implant intended for surgical placement to support restorations, which is a structural or prosthetic function rather than a therapeutic one (i.e., treating a disease or disorder).
No
Explanation: The device is a dental implant system indicated for use in surgical procedures to support dental restorations. It does not appear to be used for diagnosing medical conditions.
No
The device description explicitly states it is a dental implant made of titanium metal, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental implant system for surgical placement in the jawbone to support dental restorations. This is a surgical device, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a dental implant made of titanium metal, intended for surgical placement. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a surgically implanted medical device used for structural support in dental procedures.
N/A
Intended Use / Indications for Use
The US/GS Ultra Wide 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 US/GS Ultra Wide System is for one and two stage surgical procedures. It is not for immediate load. The US/GS Ultra Wide System is intended to be used in the molar region.
Product codes
DZE
Device Description
The US/GS Ultra Wide System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
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, molar region
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)
The US/GS Ultra Wide 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)
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.
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Image /page/0/Picture/1 description: The image shows the logo for Osstem. The logo consists of a circular design with two curved lines that intertwine to form a ring-like shape. Below the circular design, the word "osstem" is written in lowercase letters.
Osstem, Inc. One Ben Fairless Dr. Fairless Hills, PA 19030 Tel: 215.736.2990 / Fax: 215.736.2993 www.osstem.com
APR - 7 2008
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: December 3, 2007
- 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
- Device :
.
| Trade or (Proprietary) Name : | US/GS Ultra Wide System |
|---|---|
| Common or usual name : | Dental Implant |
| Classification Name : | Endosseous Dental Implant |
| 21CFR872.3640 | |
| Class II | |
| DZE |
3. Predicate Device :
The US System, Osstem Implant Co., Ltd, K062030 The GS System, Osstem Implant Co., Ltd, K063861
- Description :
The US/GS Ultra Wide 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 US/GS Ultra Wide System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and
1
Image /page/1/Picture/0 description: The image shows the Osstem logo. The logo consists of a circular design with two curved lines that do not fully connect, creating an open, flowing shape. Below the circular design, the word "osstem" is written in lowercase letters, using a simple, sans-serif font.
Osstem, Inc. One Ben Fairless Dr. Fairless Hills, PA 19030 Tel: 215.736.2990 / Fax: 215.736.2993 www.osstem.com
performance characteristics.
The US/GS Ultra Wide System is substantially equivalent in design, function and intended use to the US System(K062030) and GS System(K063861) of Osstem Implant Co., Ltd.
-
- Indication for use :
The US/GS Ultra Wide 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 US/GS Ultra Wide System is for one and two stage surgical procedures. It is not for immediate load. The US/GS Ultra Wide System is intended to be used in the molar region.
- Indication for use :
-
- Review :
The US/GS Ultra Wide System has similar material, indication for use, design and technological characteristics as the predicate device.
- Review :
The US/GS Ultra Wide 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.
- Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the US/GS Ultra Wide System is safe and effective and substantially equivalent to the predicate device as described herein
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 2008
OSSTEM Implant Company, Limited C/O Mr. MinJoo Kim Manager Osstem, Incorporated One Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K073465
Trade/Device Name: US/GS Ultra Wide System Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 17, 2008 Received: March 17, 2008
Dear Mr. Kim:
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 vour 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. Kim
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 (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.
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,
Sayite Y. Michael DMD.
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
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Image /page/4/Picture/1 description: The image shows the Osstem logo. The logo consists of a stylized circular design above the word "osstem" in lowercase letters. The circular design appears to be made of two curved shapes that partially overlap, creating a sense of depth and movement. The overall design is simple and modern.
Osstem, Inc. One Ben Fairless Dr. Fairless Hills, PA 19030 Tel: 215.736.2990 / Fax: 215.736.2993 www.osstem.com
Attachment V
Indications for Use
510(k) Number K
US/ GS Ultra Wide System Device Name:
Indication for use : The US/GS Ultra Wide 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 US/GS Ultra Wide System is for single and two stage surgical procedures. It is not for immediate load. The US/GS Ultra Wide System is intended to be used in the molar region.
| Prescription Use | X |
|---|---|
| ------------------ | --- |
(Per 21CFR801 Subpart D)
Use
OR Over-The-Counter
(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)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices |
| 510(k) Number: | K073465 |
|---|---|
| ---------------- | --------- |