(77 days)
The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are intended to be used as accessories in conjunction with the Wide Platform endosseous implant system and in the exact same manner as their counterpart predicate product.
The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are components used with various BRANEMARK SYSTEM® Wide Platform Fixtures. They include Abutments, Healing Abutments, Hand Instruments, Impression Copings and Machine Instruments.
This document is a 510(k) summary for a medical device submitted in 1996. It does not contain any information about acceptance criteria, device performance, results of any studies, or ground truth establishment.
The document is a pre-market notification that primarily focuses on:
- Device Name and Manufacturer: Nobelpharma USA, Inc.
- Device Description: Accessories for the BRANEMARK SYSTEM® - Wide Platform Fixtures (e.g., Hand Instruments, Healing Abutments, Impression Copings, Machine Instruments).
- Predicate Product: Other existing components marketed by Nobelpharma.
- Intended Use: To be used as accessories with the Wide Platform endosseous implant system, in the same manner as predicate products.
- Comparison of Technological Characteristics: States that the technological characteristics are "identical" to the corresponding predicate products.
Therefore, I cannot provide the requested information as it is not present in the provided text.
To answer your questions, I would need a document that describes the design verification and validation testing performed for the device, including:
- Specific acceptance criteria (e.g., tensile strength, dimensional accuracy, sterilization efficacy).
- Results of tests demonstrating compliance with these criteria.
- Details about the study design (e.g., sample sizes, methods for establishing ground truth, expert qualifications, adjudication methods).
§ 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.