(335 days)
For use in selected fully edentulous and partially edentulous arches.
The following table describes the indication for use for each component listed as part of this 510(k) submission:
| Component | Part
Number | Indication for Use |
|-------------------------------|----------------|-------------------------------------------------------------------------------|
| Profile UniAbutment 4.5 | 22852 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 5.5 ultra | 22855 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 5.5 | 22856 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 7.0 | 22860 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 4.5 | 22782 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 5.5 ultra | 22785 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 5.5 | 22786 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 7.0 | 22790 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 4.5 | 22870 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 5.5 | 22872 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 7.0 | 22874 | Prepable component that is placed in fixture for cemented bridge construction |
| Abutment Screw ST, short | 22554 | Screw that is used to attach the Profile BiAbutment ST to the fixture |
The Prepable Abutment System is comprised of a selection of components for prosthetic and laboratory procedures for single-tooth and multiple tooth constructions. The additional components provided for by this 510(k) are added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. All implants are made from commercially pure titanium. The indications and uses for these additional components are not different from similar components of the predicate device.
This 510(k) summary (K974738) is for "Astra Tech Implants - Dental System Prepable Abutment System - ADDITIONAL COMPONENTS." This device appears to be an update or expansion of an existing dental implant system, specifically adding new abutment components.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) notification and the FDA's response letter indicating substantial equivalence to predicate devices. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than on new clinical performance studies with acceptance criteria, which are typically required for Novel devices or PMA submissions.
Therefore, I cannot fulfill the request to provide information about acceptance criteria and a study that proves the device meets those criteria because that information is not present in 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.