(106 days)
Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and 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.
The Straumann Regular 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 for single-stage or two-stage surgery.
The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4. 1 mm dental implant.
The Straumann Dental Implant with anodized neck is a minor modification of cleared Straumann Dental Implants. The implants with anodized neck are available in two neck sizes, RN diameter 4.8 mm and NN diameter 3.5 mm. The design of the modified implants is identical to the predicate implants. There is no change to the endosseous grit blasted, acid etched SLA surface. The subject implants have the same material composition and the same endosseous surface treatment as previously cleared Straumann implants. In addition, the design of the implant is identical to the predicate devices.
This submission does not contain information about acceptance criteria or a study proving that a device meets such criteria. It is a 510(k) summary for Straumann Anodized Neck Implants, focusing on demonstrating substantial equivalence to previously cleared predicate devices. The document highlights that the new device is a minor modification (anodized neck for aesthetic purposes) and shares the same material composition, endosseous surface treatment, and implant design as the predicate devices. Therefore, the requested information cannot be extracted from the provided text.
§ 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.