(215 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 patient's chewing function.
· Two stage: MPI, ULT, API and CPI models
- · One stage: OPI and TPI models
The 3.3 and 3.0mm diameter models for One stage OPI and TPI, Two stage and API 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, ULT, API, CPI, OPI and TPI are self-tapping Titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and longterm fixation of new or existing crown, bridge and prosthesis and protection of graft sites.
MPI, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate occlusal loading.
MPI, ULT, API, CPI, OPI and TPI are indicated for immediate loading (except for MPI and API in 6.0mm length) 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.
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 type: TPI (Tissue Level (One Piece) Precision Implant) -The TPI design is based on Ditron's cleared MPI Implant model and the 3.0mm Straight Multi-Unit Abutment, creating a one-piece implant. The TPI's implant part is identical to the cleared MPI Implant model, and the 3.0mm MPI Straight Multi-unit part has minor dimensional modifications and color anodization for aesthetic purposes. The TPI compatible Cover and Prosthetic Screws are color anodized as well.
An additional Abutment type: TPI Healing Caps Abutment -● The TPI Healing Caps design is based on Ditron's cleared Cylindered Healing Caps. The TPI Healing Caps are color-anodized for aesthetic purposes. The TPI Healing Caps Abutments are available in several Gingival height dimensions of 3.5, 4.5 and 5.5mm.
- . Modification to Cleared Titanium Abutments – Addition of color anodization as an option for all of the Ditron Dental System Titanium Alloy Grade 23 (Ti 6Al-4V ELI) Abutments cleared under K140727 and K161497, to enhance the aesthetic outcome of the dental prosthetics.
- An additional Abutment type: TPI Titanium Coping Abutments The TPI ● Titanium Coping Abutment design is based on Ditron's cleared Temporary Abutment. The TPI Titanium Coping Abutments are directly connected to the endosseous dental implant and are intended to provide a basis for prosthetic restoration of single (Crown) or multiple teeth (Bridge). The TPI Titanium Coping Abutment is available in several lengths and restoration options: 11.0mm Bridge, 11.0 Crown, 4.5mm Bridge, 4.5mm Crown.
- An additional Abutment type: TPI Overdenture Liberator Abutment The TPI ● Overdenture Liberator Abutment design is based on Ditron's cleared Liberator Abutment. The Liberator Abutment is available in several length dimensions of 2.0, 3.0, 4.0 and 5.0mm.
I am sorry, but the provided text focuses on the substantial equivalence of the "Ditron Dental Implants and Abutments" against predicate devices, primarily discussing changes and additions to the product line and the non-clinical testing performed to support their substantial equivalence for FDA clearance.
The document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria for aspects like:
- A table of acceptance criteria and reported device performance: While there's a substantial equivalence table, it compares features and does not list specific acceptance criteria with reported device performance values for a study.
- Sample size used for the test set and data provenance: The document mentions non-clinical tests but does not specify sample sizes for test sets (e.g., how many implants were used for fatigue testing, beyond stating "worst case configuration"). It also doesn't discuss data provenance in terms of country of origin or retrospective/prospective for a clinical study.
- Number of experts used to establish ground truth and their qualifications: This type of information is relevant for studies involving human interpretation (e.g., image analysis devices), which is not the nature of this submission.
- Adjudication method for the test set: Similarly, this is not applicable here as there isn't a "test set" requiring expert adjudication in the context of device performance in a clinical or reader study.
- Multi Reader Multi Case (MRMC) comparative effectiveness study and effect size: This type of study is for evaluating human performance with and without AI assistance, which is not applicable to dental implants and abutments.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
- Type of ground truth used: For physical device testing, ground truth refers to validated measurements or established standards (e.g., ISO standards for fatigue). The document states tests were conducted "with accordance to ISO 14801" for fatigue, but doesn't elaborate further on a "ground truth" as might be understood in AI/clinical studies.
- Sample size for the training set: Not applicable as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
The document primarily demonstrates that the new dental implant and abutment variations are substantially equivalent to previously cleared devices based on their identical or similar indications for use, technological characteristics (materials, design, sterilization), and non-clinical performance data (biocompatibility, sterilization validation, surface testing, fatigue testing, shelf life, MRI compatibility). The non-clinical tests performed served to ensure the safety and effectiveness of the new devices align with the predicate devices and established standards.
Therefore, I cannot extract the specific information you requested from the provided text for a "study that proves the device meets the acceptance criteria" in the format you outlined.
§ 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.