(207 days)
The Ditron Dental Implant and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
- Two stage: MPI, CPI
- · One stage: OPI
One stage and One piece OPI 3.3 and 3.0 mm diameter implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.
Two stage and One stage implants for temporary or long-term use: MPI, CPI, OPI are self-tapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites. MPI, CPI and OPI designs are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
MPI, CPI and OPI are indicated for immediate loading in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.
The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.
The Ditron Dental Implants and Abutments consist of one and two stage endosseous form dental implants, internal hexagonal implants and external hexagonal abutments, one piece implants system, cover screws and healing caps; abutment systems and superstructures and surgical instruments.
The Molecular Precision Implant (MPI) features an expanding tapered implant body. It is available in lengths of 8.0 mm, 10 mm, 11.5 mm. 13 mm and 16 mm with diameters of 3.5mm, 3.75 mm, 4.2 mm, 5.0 mm and 6.0 mm, except for the 16 mm length which is not available with a diameter of 6.0 mm.
The Cylindrical Precision Implant (CPI) is a cylindrical implant. It is available in lengths of 8.0 mm, 10 mm, 11.5 mm, 13 mm and 16 mm with diameters of 3.75 mm, 4.2 mm, 5.0 mm and 6.0 mm, except for the 16 mm length which is not available with a diameter of 6.0 mm.
The One Piece Implant (OPI) is a one piece implant with an integral abutment designed for one stage procedure and cemented restorations. It is available in lengths of 8, 10, 11.5, 13 and 16 mm with diameters of 3.0 and 3.3 mm Straight Abutments can be used with two platforms; normal and slim. The straight abutments are available at the following lengths of 11.5 and 8.5 mm with a diameter of 4.5 mm, length of 8.5 mm and 6 mm with a diameter of 3.8 mm, length of 2 and 4 mm with a diameter of 5.6 mm.
The Anatomic Angulated Abutment has an anatomic configuration with ascending and descending shoulders the height of the neck varies between 1, 2 and 3mm and is available in 2 different lengths; 1 and 3 mm. These abutments are available with angles of 15° and 25°.
Angulated Abutments are suitable for multi-unit implant restorations and are available with angles of 15° and 25° with lengths of 8.5 mm and 11.5 mm. Ball Retained Abutments feature a titanium ball for overdenture restoration and are available in the following dimensions: 0.5, 2, 3, 4, 5 and 6 mm. Less than 4mm post-height are suitable only for multi-unit loaded restorations.
Temporary Abutments require no cement and are supplied at lengths of 1, 2, 3, 5 and 7 mm.
Bar Retained Abutments less than 4mm post-height are suitable only for multiunit loaded restorations and are supplied in the following dimensions: 0.5, 1.5, 2.5 mm.
Multi-Unit Bar Retained Abutments provides support and retention for mutiunit screw-retained restorations and are available in two heights: 0.5mm and 1mm, and; two angles: 17° and 30° for each height for multi-unit loaded restorations.
Screw Retained Abutment is a supporting structure used to support lateral or horizontal pressure as an anchorage for single tooth or more (bridge). The package is supplied with the abutment and the matching screw. Less than 4mm post-height are suitable only for multi-unit loaded restorations or for single-unit loaded restorations if used in combination with plastic sleeve per Ditron labeling. Cover screw is made of titanium and supplied sterile with the implant.
All implants and body contact abutments are made of biocompatible Titanium 6A1-4V-ELI.
The provided text is a 510(k) premarket notification for Dental Implants and Abutments. It primarily focuses on demonstrating substantial equivalence to predicate devices and includes information about the device's design, materials, and intended use. However, it does not contain specific acceptance criteria, reported device performance data, details of a study proving meeting acceptance criteria, or information regarding sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.
Therefore, I cannot provide the requested information in the format of acceptance criteria and study details. The document states that "A series of safety and performance tests and evaluations were performed to demonstrate that Ditron's Dental Implant System does not raise any new issues of safety and effectiveness. These evaluations include fatigue, surface analysis, biocompatibility, sterilization validation and shelf life validation in order to assure maintaining of SAL 10to along the shelf life." However, it does not provide the specific numerical acceptance criteria or the results of these tests.
The document's purpose is to establish substantial equivalence for a physical medical device, not to present performance data for an AI/ML system.
§ 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.