(80 days)
Ditron's Dental Implants 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 chewing function of patients with fully or partially edentulous:
- Two stages: MPI, ULT, API, CPI, MPC, APC, CPC and UPC models .
- . One stage: OPI and TPI models
The 3.3mm and 3.0mm diameter implants (OPI and TPI. MPI and API) are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.
The Two stages and One stage implants are indicated for temporary or long-term use. They are selftapping 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, ULT, API, CPI, OPI, TPI, MPC, APC, CPC and UPC models are indicated for immediate loading (except for MPI. and API 6mm length) in single- and multi-tooth restoration, when good primary stability is achieved and 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 Temporary Titanium and PEEK Abutments are indicated to be used on Ditron implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.
This submission covers changes related to Ditron's Dental implants and abutments. The inclusion of additional product variations aims to provide dental surgeons with a broader range of implant and abutment options for patient treatment.
The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:
. An additional implant types:
- MPC (Conical Connection Molecular Precision Implant) o
- O APC (Conical Connection Advanced Precision Implant)
- UPC (Conical Connection Ultimate Precision Implant) O
- CPC (Conical Connection Cylindrical Precision Implant) O
The Conical Connection (CC) implants include a conical connection platform (Morse taper). The intended use, materials, drilling protocol, thread designs and bone interface of the subject Conical Connection implants (MPC, UPC, APC and CPC) are identical to Ditron's cleared Internal Hex connection platform implants (MPI, ULT, API and CPI, respectively). The CC implants include color anodization for aesthetic purposes. The CC compatible Cover and Prosthetic Screws are color anodized as well.
The MPC/APC/CPC/UPC Implants are available in diameters of 3.5mm, 4.2mm, 5.0mm, and 6.0mm, with lengths of 8.0mm, 11.5mm, 12mm, 13mm, 14mm, and 16mm. Additionally, a 6.5mm length is offered for MPC/APC/CPC implants in 4.2mm, 5.0mm, and 6.0mm diameters, and a 7.0mm length is available for UPC implants in 4.2mm, 5.0mm, and 6.0mm diameters.
- An additional Abutment type: CC Healing Caps and SRA Healing Caps Abutments The CC Healing Caps are color-anodized for aesthetic purposes. They are used for the maintenance of the soft tissue during the osseointegration phase of Ditron CC implants to be rehabilitated using technique. They are available in diameters of 3.5, 4.5 and 5.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5 and 4.5mm.
- An additional Abutment type: CC Cement Retained Abutments the CC Anatomic/Universal . straight/angulated abutments are Cement-Retained Abutments. They are intermediary prosthetic components to be installed onto Ditron's CC implants to support the final prosthesis. They are available as straight (0°) or angulated (15° and 25°) in diameters: 3.5, 4.5 and 5.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5 mm.
- . An additional Abutment type: CC Single-Unit and Multi-Unit Abutments - The CC Screw-retained Single Unit Abutment and Multi Unit Abutments are intermediary prosthetic components to be installed onto CC Ditron's implants to support the final prosthesis. They are available as straight (0°) or angulated (17° and 30°) and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.0 mm. The Single Unit abutment height is up to 4.5mm only.
- An additional Abutment type: CC Temporary Titanium Abutments The CC Temporary Titanium Abutments are temporary intermediary prosthetic components to be installed onto the Ditron's CC implants to support the provisional prosthesis for up to 6 months. They are available as straight (0°) in diameters: 3.5 and 4.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5mm.
- An additional Abutment type: CC Temporary PEEK Abutments The CC Temporary PEEK Abutments are temporary intermediary prosthetic components to be installed onto Ditron's CC implants to support the provisional prosthesis for up to 6 months. They are composed of a customizable cylindrical body made of PEEK and a non-customizable base made of titanium. They are available in diameters of 4.5 and 6.0mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5mm.
- An additional Abutment type: CC Liberator Overdenture Abutment The CC Liberator Overdenture Abutment is similar in design to Ditron's cleared Liberator abutment, except for the addition of Titanium Nitride (TiN) coating on the subject device. It is available in the following gingival heights: 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0mm.
- An additional Abutment type: SRA Titanium Coping Abutments The SRA Titanium Coping . Abutment is suitable for use with the CC Screw-retained single Abutments. It connects to the abutment using one of the designated abutment screws. They are available in short (L4.85mm) and long (L11mm) versions.
- Modification to Cleared Titanium Abutments Addition of Laser Marking for identification as an option for all of the Ditron Dental cleared Titanium Abutments (K140728, K161497, K233231).
- Modification to Cleared Liberator and TPI Overdenture Abutments Addition of TiN coating to . Ditron's cleared Liberator abutment (K161497) and the cleared TPI Liberator Overdenture Abutment (K233231).
The provided text does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is a 510(k) summary for Dental Implants and Abutments, focusing on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data. It does not mention any AI/ML components or related studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results (effect size).
- Standalone performance study for an algorithm.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.