(99 days)
IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.
IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems. IPD Dental Implant Abutments includes the following categories of dental abutment designs: Healing abutments; Temporary abutments; Cementing titanium abutments; Titanium base (interface) abutments; The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant.
This is a Premarket Notification (510(k)) summary for the IPD Dental Implant Abutments. This document does not describe a study proving the device meets acceptance criteria as would be found in a clinical trial for a novel AI device with specific performance metrics. Instead, it demonstrates substantial equivalence to predicate devices based on bench testing and engineering analysis.
Here's an breakdown of the information provided, tailored to your request, but emphasizing that this is not a typical AI/ML performance study:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for dental abutments, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity/specificity for an AI model), but rather as compliance with recognized standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" refers to successful completion of various non-clinical tests.
| Acceptance Criteria (Demonstrated Equivalence/Compliance) | Reported Device Performance (Test Results) |
|---|---|
| Same intended use as predicate device | Intended use is identical |
| Same operating principle as predicate device | Operating principle is identical |
| Similar design and same device categories | Very similar design, same categories |
| Same materials and surface coatings | Identical materials and surface coatings |
| Same sterilization processes | Identical sterilization processes |
| Sterilization validation (SAL of 1 x 10^-6) | Met ISO 17665-1 requirements |
| Biocompatibility: Cytotoxicity | Non-cytotoxic (ISO 10993-5 met) |
| Biocompatibility: Sensitization (TiN coated) | Met ISO 10993-10 requirements |
| Biocompatibility: Irritation (TiN coated) | Met ISO 10993-23 requirements |
| Mechanical compatibility (with OEM implants) | Confirmed by reverse engineering/dimensional analysis |
| Validation of digital workflow and software system | Ensured design/manufacturing within parameters |
| Static and dynamic fatigue testing | Met ISO 14801 requirements (worst-case configurations) |
| MRI safety (magnetically induced displacement force/torque) | Reviewed using scientific rationale and published literature, parameters addressed per FDA Guidance |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of human data or AI model test sets. The "test set" here refers to the physical samples of the IPD Dental Implant Abutments (and their components, potentially in various configurations) that were subjected to the specified bench and biocompatibility tests. The exact number of physical abutments, screws, or zirconia superstructures tested for each specific criterion is not detailed in this summary but would be found in the full test reports.
- Data Provenance: Not applicable in the context of country of origin for patient data. The tests were performed on the manufactured device components. The materials are specified (e.g., Titanium alloy conforming to ISO 5832-3).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this context would generally refer to expert-derived labels for clinical data, which is not part of this 510(k) submission. The "truth" for the performance tests is established by adherence to recognized international standards (e.g., ISO, FDA Guidance) and objective measurements from engineering or biological tests.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human readers or expert labelers of clinical data, which is not relevant here. The evaluation criteria for the bench tests are objective and defined by established standards.
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
No. This device is a dental implant abutment, not an AI software. Therefore, MRMC studies and AI assistance effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device (dental abutments), not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by:
- Compliance with international standards (e.g., ISO 14801 for fatigue testing, ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization).
- Engineering specifications and dimensional analysis to ensure compatibility with other specified dental implant systems.
- Validated digital dentistry workflow parameters (e.g., minimum gingival height, wall thickness, post height, angulation for zirconia superstructures), which are based on established dental prosthetic principles.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is used for this physical device.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)