(49 days)
The Nobelpharma BRÅNEMARK SYSTEM - MK II Self-Tapping Fixtures are intended to be used in edentulous and partially edentulous patients to restore chewing functions.
The Nobelpharma BRÅNEMARK SYSTEM - Mk II Self-Tapping Fixture is a line of endosseous implants, varying in diameter, which are implanted in the upper and lower jaw bone to be used to support prosthetic devices to help restore chewing functions of edentulous patients. The device has been cleared for sizes 3.75, 4.0, 4.4, 5.0 and 5.5mm diameters. The only modification is to the 5.0 and 5.5mm diameter fixtures. This modification of the 5.0mm and 5.5mm diameter fixtures entails 1) an increased internal thread diameter for insertion of appropriate abutment screws and 2) an increased hexagonal dimension for the hex portion of the fixture to facilitate accurate seating of appropriate abutments. An additional minor modification to the flange (a 0.4mm increase of diameter) and to the apex (a 0.3mm increase in diameter) is being made to the 5.5mm fixture to accommodate the surgical and prosthetic components of the system.
This request cannot be fulfilled. The provided text describes a medical device (an endosseous implant) and its specifications, but it does not contain information about acceptance criteria, device performance studies, or AI/software validation. The document is a 510(k) summary from 1996 for a physical implant device, not a diagnostic or AI-powered medical device that would involve the type of study details you're asking for.
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K962130
Premarket Notification June 1, 1996 Page 3
JUL 22 1
The 22 1998
VI. 510(k) Summary of Safety and Effectivenes
A. Name and Address
This Summary of Safety and Effectiveness is being submitted by Nobelpharma USA, Inc. 777 Oakmont Lane, Suite 100, Westmont, IL 60559. The telephone number is (708)654-9100. The contact person will be the Director, Regulatory Affairs. This summary was prepared on May 31, 1996.
B. Name of the Device
This device is generally known as an endosseous implant with the trade name "Nobelpharma BRÅNEMARK SYSTEM® - Mk II Self-Tapping Fixture. This submission is a modification to a previously cleared device of the same name in K945398
C. The Predicate Product
The predicate product used in this Premarket Notification is the previous version of the same device, Mk II Self-Tapping Fixture in sizes 5.0 and 5.5 mm diameter and varying lengths, K945398.
D. Description of the Device
The Nobelpharma BRÅNEMARK SYSTEM - Mk II Self-Tapping Fixture is a line of endosseous implants, varying in diameter, which are implanted in the upper and lower jaw bone to be used to support prosthetic devices to help restore chewing functions of edentulous patients. The device has been cleared for sizes 3.75, 4.0, 4.4, 5.0 and 5.5mm diameters. The only modification is to the 5.0 and 5.5mm diameter fixtures. This modification of the 5.0mm and 5.5mm diameter fixtures entails 1) an increased internal
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Premarket Notification June 1, 1996 Page 4
thread diameter for insertion of appropriate abutment screws and 2) an increased hexagonal dimension for the hex portion of the fixture to facilitate accurate seating of appropriate abutments. An additional minor modification to the flange (a 0.4mm increase of diameter) and to the apex (a 0.3mm increase in diameter) is being made to the 5.5mm fixture to accommodate the surgical and prosthetic components of the system.
E. Intended Use of the Device
The Nobelpharma BRÅNEMARK SYSTEM - MK II Self-Tapping Fixtures are intended to be used in edentulous and partially edentulous patients to restore chewing functions.
F. Comparison of Technological Characteristics
The technological characteristics between the previously cleared 5.0 and 5.5mm diameter Mk II fixtures are identical. The material used in both devices is the same as is the general shape and structure. The only changes for both the 5.0 and 5.5mm diameter fixtures are minor dimensional changes to accommodate placement of the appropriate abutment screws and abutments.
§ 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.