(126 days)
S3M Klockner implants are a dental implant which consist of a small conical fixture (the root-form configuration). This implant enabling to be used as a support fitting when the gap to be replaced is not sufficient for a standard fitting (Ø 4.2 mm shoulder), or in areas of aesthetic concern, where the long-term preservation of the papilla is very important, such as the upper lateral incisors and lower incisors.
The S3M Klockner implant are an endosseous implant, are a device made of Grade 3 commercially pure titanium , which consist of a small conical fixture (the root-form configuration), perhans eigth to fourteen millimetres in length that have a shot peening process and a pasivated surface. Are available in diameter 3.1mm.
The provided document is a 510(k) premarket notification for a dental implant. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested.
Specifically, the document primarily focuses on establishing "substantial equivalence" of the KLOCKNER dental implants (S3M) to previously cleared predicate devices. This regulatory pathway does not typically involve the detailed performance studies with acceptance criteria, sample sizes, expert ground truth, and statistical analysis that would be present for a new device requiring a PMA or a more extensive de novo submission.
Here's why the requested information cannot be extracted from the provided text:
- No detailed performance study: The document mentions "Mechanical testing was done in accordance with the FDA guidance «Information for premarket notification submissions for screw type endosseous implants» issued on December 9, 1996. Results from an independent laboratory showed that the surface treatment to have sufficient osseointegration. Additional test reports include finite elements analysis." However, it does not provide the specific acceptance criteria for these tests, the actual results, or the methodology of the "independent laboratory study" beyond that.
- Focus on Substantial Equivalence: The primary assertion is that the device is "substantially equivalent" to predicate devices (S3 KLOCKNER DENTAL IMPLANTS and NARROW NECK ITI STRAUMANN). This generally means demonstrating similar materials, design, indications for use, and performance characteristics without necessarily conducting new, exhaustive clinical trials or performance studies against predefined acceptance criteria for novel claims.
Therefore, I cannot populate the table or answer the specific questions as the required data is not present in the provided text. The document is a regulatory submission demonstrating equivalence, not a detailed scientific study report with acceptance criteria and results.
§ 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.