Search Results

Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
TRI Screws are intended to secure TRI-matrix® Crown Abutments to TRI-matrix® implants.

Dynamic TiBase abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. All subject device bases are made of titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The Dynamic TiBase abutments are provided in engaging designs for single-unit restorations.
Dynamic TiBase abutments are provided in sizes compatible with the following SGS® Dental Implants System implants:
SGS P1D, Conical connection, 5.0 mm body diameter, 3.5 (3.0 mm) platform; and
SGS P7N, Narrow Conical connection, 3.2 mm body diameter, 2.1 (2.5 mm) platform.
All Dynamic TiBase abutments are provided in a straight design (no angulation in the TiBase portion). All Dynamic TiBase abutments have a prosthetic post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary.
For the compatible SGS P1D Concal connection implant, the Dynamic TiBase abutments are provided with a gingival height (in the titanium base) of 0.5 mm, or 3.0 mm, and a prosthetic platform diameter of 4.3 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. For the compatible SGS P1D Conical connection implant, the abutments have a prosthetic post height (length above the gingival height) of 4.0 mm, and a cut-out height of 2.5 mm.
For the SGS P7N Narrow Conical connection implant, the gingival height (in the titanium base) is 0.5 mm or 1.5 mm. and a prosthetic platform diameter of 3.8 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. For the compatible P7N Narrow Conical connection implant the abutments have a prosthetic post height (length above the gingival height) of 4.5 mm, and a cut-out height of 2.5 mm. Dynamic TiBase abutments with a 4.5 mm maximum post height may be shortened to no less than 4 mm for a single-unit restoration.
The subject device TRI Screws are to be used only to attach TRI-matrix® Crown Abutments. The TRI-matrix® Crown Abutments and TRI-matrix® implants are manufactured by TRI Dental Implants Int. AG and were cleared in K203660. The TRI screws have a hexalobular instrument interface, a screw head diameter of 2.6 mm, 1-72 UNF thread, and an overall length of 5.15 mm or 7.6 mm. The TRI Screws are anodized to a gold color and are only intended to be used with straight abutments. The compatible abutments are made from zirconia and are for direct final restorations.

This is a substantially equivalent (SE) determination letter from the FDA, not a study report. It states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics. Therefore, it does not contain the detailed information about acceptance criteria and study results you requested for a novel device.

The document states that a non-clinical mechanical testing study was performed to support the performance of the abutments and zirconia superstructure. However, the specific acceptance criteria and detailed results of this study are not provided in this regulatory document.

Here's a breakdown of what can be extracted or inferred based on your request, and what is explicitly not available:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion for this FDA clearance is "substantial equivalence" to predicate devices. This means the device has the same intended use and similar technological characteristics (materials, design, manufacturing, sterile processing, etc.), and any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that mechanical testing conducted according to ISO 14801 was performed to support the performance of the subject device abutments in conjunction with compatible OEM implants. It also mentions a "non-clinical worst-case MRI review" using scientific rationale and published literature. However, the specific numerical acceptance criteria for these tests (e.g., specific fatigue limits, displacement values) and the actual quantitative results are not provided in this summary. It only states that these tests were performed to mitigate risks.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided in the document. The mechanical testing would have involved a specific number of samples (e.g., implant-abutment assemblies) tested according to ISO 14801. The document only states that such testing was performed to demonstrate performance. The country of origin for the testing data is not mentioned, but the manufacturer is Talladium España, SL (Spain).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This kind of information is not applicable to this type of regulatory submission (Class II dental implant components). There is no "ground truth" established by experts in the context of diagnostic accuracy for this device. The assessment is based on engineering principles, materials science, and mechanical testing against recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This is not applicable as it pertains to expert consensus in diagnostic studies, not mechanical testing of medical devices.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This is not applicable. This is a physical dental implant component, not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This is not applicable. This is a physical dental implant component, not an AI diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the mechanical testing, the "ground truth" would be the physical properties and mechanical integrity of the device measured against predetermined performance specifications outlined in relevant ISO standards (e.g., ISO 14801 for fatigue testing of dental implants). For biocompatibility, it's testing against ISO 10993 standards.

8. The sample size for the training set

• This is not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

• This is not applicable.

Summary of available and missing information regarding acceptance criteria and study:

This document is a regulatory communication affirming substantial equivalence based on non-clinical data, not a detailed scientific study report. For the specific acceptance criteria and quantitative performance results, one would typically need to refer to the full 510(k) submission, which is not publicly available in this level of detail.

Ask a specific question about this device

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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
7. 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.
8. Sample size for the training set: Not applicable as this is not an AI/machine learning device.
9. 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.

Ask a specific question about this device