(134 days)
IDI Implant Systems (IDI Fixtures and IDI Abutments with screws) are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artifical tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
IDI Implant Systems are threaded root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments which provide cemented and screw retained restorative options.
This document is a 510(k) summary for the IDI Implant Systems, an endosseous dental implant. It focuses on regulatory approval rather than a detailed study proving device performance against specific acceptance criteria. Therefore, most of the requested information regarding an AI medical device study is not present in this document.
However, I can extract the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not contain a table of acceptance criteria or reported device performance for an AI medical device. Instead, it describes a dental implant system. The "acceptance criteria" in this context would likely refer to engineering specifications and biocompatibility, which are not detailed in this regulatory summary.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This document describes a dental implant, not an AI medical device evaluated with a test set of data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. This document describes a dental implant, not an AI medical device that requires expert-established ground truth from a test set.
4. Adjudication Method for the Test Set:
Not applicable. This document describes a dental implant, not an AI medical device that would involve adjudication for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This document describes a dental implant, not an AI medical device that would typically undergo an MRMC study.
6. Standalone Performance Study:
Not applicable. This document describes a dental implant, not an AI medical device that is evaluated for standalone algorithm performance.
7. Type of Ground Truth Used:
Not applicable. This document describes a dental implant. The "ground truth" for a dental implant would be its physical properties, biocompatibility, and clinical performance as demonstrated through other means (e.g., mechanical testing, animal studies, clinical use data, but not typically in the sense of 'ground truth' for an AI system).
8. Sample Size for the Training Set:
Not applicable. This document describes a dental implant, not an AI medical device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This document describes a dental implant, not an AI medical device that requires ground truth for a training set.
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510(k) Summary of Safety and Effectiveness
| Submitted by: | William Hung, DDS., JD.CEO |
|---|---|
| Address: | IDI Biomedical LLC34859 Frederick St #107Wildomar CA 92595 |
| Telephone: | 951-288-8819 |
| Fax: | 909-621-9959 |
| Date of Submission: | June 9, 2008 |
| Classification Name: | Endosseous dental implant 21 CFR 872.3640 and endosseous dentalimplant abutment 21 CFR 872.3630 |
| Trade Name: | IDI Implant Systems |
NOV - 7 2008
Legally Marketed Device: NobelReplace Hexagonal Implant K073142
Device Description:
IDI Implant Systems are threaded root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments which provide cemented and screw retained restorative options.
Indications for Use:
ID1 Implant Systems (IDI Fixtures and IDI Abutments with screws) are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artifical tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2008
IDI Biomedical LLC C/o Ms. Angela Blackwell Senior Consultant Biologics Consulting Group 104 2nd Street SE Catawba, North Carolina 28609
Re: K081806
Trade/Device Name: IDI Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 4, 2008 Received: November 4, 2008
Dear Ms. Angela Blackwell:
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.
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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) promarket 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snyte H. Nickau Mrs.
Chiu S. Lin. Ph. D DR. CHILL LIN Division 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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Indications for Use:
510(k) Number (if known): K081806
Device Name: IDI Implant system
Indication For Use:
IDI Implant System are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and nonsplinted applications. The device' is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
| Prescription Use x | Over-The-Counter Use __________ |
|---|---|
| (Part 21 CFR801 Subpart AND/OR | (21 CFR 801 Subpart . |
| D) | C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K081806 |
|---|---|
| ---------------- | --------- |
§ 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.