(308 days)
BioHorizons implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.
BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored using delayed loading, or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures.
BioHorizons Tapered Internal 3.0, Tapered Tissue Level 3.0 Implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion, (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.
Intra-Lock implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.
Intra-Lock 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion, (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.
Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications.
Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.
MILO™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function. They are also indicated for the rehabilitation of single maxillary lateral incisors and mandibular lateral incisors. The implants may be restored after a period of time or placed in immediate function.
BioHorizons Prosthetics are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.
BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used as straight abutments.
The BioHorizons Multi-unit Abutments for CONELOG® are intended to function in the mandble or maxilla to support single and multiple-unit temporary or definitive restorations on CONELOG dental implants.
BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm and 5.7mm internal hex-connection mating platform diameters. All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.
Intra-Lock Prosthetics are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with Intra-Lock implants.
Intra-Lock Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used as straight abutments.
Intra-Lock CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with Intra-lock implants. All digitally designed abutments and/or copings for use with Intra-Lock CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. Intra-Lock abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.
The MILO and Mini Drive Lock Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.
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The provided text is a clearance letter and Indications for Use statement for BioHorizons dental implants and abutments regarding their MRI compatibility. It does not contain any information about an AI/ML device, its acceptance criteria, or performance studies. Therefore, I cannot extract the requested information.
The document pertains to the regulatory clearance of a medical device (dental implants) for use in an MRI environment, not an AI or machine learning product. It describes the physical characteristics and intended use of the implants in a traditional medical context.
To provide the requested information, a document describing an AI/ML device and its validation studies would be necessary.
§ 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.