(244 days)
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCI). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.
The BLC and TLC implants features the TorcFit connection and are available in the maximum endosteal outer diameters ø 3.3 mm, ø 3.75 mm, ø 5.5 mm and Ø 6.5 mm.
The BLC implants are available with the following length options:
- L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm.
- L 6 mm to L 18 mm for diameters Ø 3.75 mm and Ø 4.5 mm
- L 6 mm to L 16 mm for diameter Ø 5.5 mm
- L 6 mm to 14 mm for diameter Ø 6.5 mm.
The subject BLC implants are presented with RB (Reqular Base) and WB (Wide Base) prosthetic platform.
The TLC implants are available with the following length options:
- L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm,
- L 6 mm to L 18 mm for diameters ø 3.75 mm and ø 4.5 mm
- L 6 mm to L 12 mm for diameter Ø 5.5 mm
- L 6 mm to 10 mm for diameter Ø 6.5 mm.
The subject TLC implants are presented with the NT (Narrow TorcFit) RT (Regular TorcFit) WT (Wide TorcFit) prosthetic platform. The implant neck is available either as Standard (2.8 mm height) or Standard Plus (1.8 mm height) option.
The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device. The document is an FDA 510(k) summary for Straumann® BLC and TLC Implants, which are endosseous dental implants, not an AI/ML device.
Therefore, I cannot provide the requested information.
§ 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.