(139 days)
Straumann Narrow Neck implants are intended for single-stage or two-stage surqical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Straumann Narrow Neck implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.
The Straumann Narrow Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants have an SLA or SLActive surface and have the same design and dimensions as the predicate device.
The provided text is a 510(k) Summary and FDA clearance letter for a medical device, specifically dental implants. It does not contain information about acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria.
The 510(k) summary focuses on establishing substantial equivalence to previously cleared predicate devices. This type of submission generally does not require new clinical studies with defined acceptance criteria and performance metrics in the same way a PMA (Pre-Market Approval) or de novo submission would. Instead, the focus is on demonstrating that the new device is as safe and effective as a legally marketed device.
Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The document explicitly states:
- "The subject Narrow Neck implants are substantially equivalent to the previously cleared Straumann implants, K010291, K03007 and K053088. There is no change to the implant design or dimensions. The intended use is identical to predicate devices."
- The FDA letter confirms "determined the device is substantially equivalent... to legally marketed predicate devices."
This indicates that the clearance was based on similarity to existing devices, not on a new study with the type of rigorous performance testing and acceptance criteria you've asked for.
§ 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.