(219 days)
PerioType Rapid Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients for loading after healing or immediate loading provided that stability requirements are satisfied.
PerioType Rapid Implants are threaded, root-form dental implants
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental implant device called "Periotype Rapid." This document does not contain information about acceptance criteria, device performance, study details for a test set, ground truth for training or testing, or a multi-reader multi-case comparative effectiveness study. It primarily focuses on the device's substantial equivalence to predicate devices and the regulatory framework.
Therefore, I cannot extract the requested information from the given text. The text does not describe a study that proves the device meets specific acceptance criteria in the context of AI/ML performance metrics.
The document states:
- Trade/Device Name: Periotype Rapid
- Regulation Number: 21 CFR 872.3640
- Regulation Name: Endosseous Dental Implant
- Regulatory Class: Class II
- Product Code: DZE
- Indications for Use: PerioType Rapid Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients for loading after healing or immediate loading provided that stability requirements are satisfied.
§ 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.