(299 days)
The Atlantis abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The impression coping is intended to transfer the position of the implant in the oral cavity to a working cast. The impression coping screw is intended to temporarily secure the impression coping to either the implant fixture or the analog fixture.
The Atlantis Abutment is used to connect an implanted fixture to a restoration.
The Atlantis abutment is an abutment used with an endosseous implant that is implanted in the upper or lower jawbone. The abutment sits on the implant interface and is retained by the Atlantis screw. The abutment allows the option for the prostheses to be cemented directly to the abutment, or to be retained by a screw. The abutment is ordered by prescription from a Dentist, then is designed and manufactured by Atlantis to that prescription.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the Atlantis Abutment System, which focuses on:
- Identification of the device: Description, intended use, classification.
- Comparison to a predicate device: Stating that the technological characteristics are "identical" to a previously cleared device.
- FDA clearance letter: Confirming substantial equivalence based on the provided information.
There is no mention of specific performance metrics, acceptance criteria, study design, sample sizes, ground truth establishment, or any results from a performance study. This is typical for a 510(k) submission where substantial equivalence to a predicate device is claimed, often without needing to conduct new performance studies if the technological characteristics are deemed identical and safety/effectiveness are established through the predicate.
§ 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.