(77 days)
To serve as artificial root structures for single teeth or bridge abutments for bridgework in edentulous sites with adequate bone of sufficient quality to support the implant and function.
Saber Tech Implants System (GIS) endosseous implant
The provided text is a 510(k) premarket notification letter from the FDA to IMTEC Corporation regarding their Saber Tech Implants System (GIS) Endosseous Implant. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter explicitly states: "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..."
This means the device was approved based on substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample size or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone performance study.
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This document is a regulatory approval letter based on substantial equivalence, not a clinical trial report or a performance study.
§ 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.