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510(k) Data Aggregation
(209 days)
The DIMPLO Implant System is intended for use in the maxilla or mandible of partially or fully edentulous patients to support single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, as well as terminal or intermediate abutment support for fixed bridgework. It is intended for two-stage surgical procedures and may be used for immediate loading when good primary stability and appropriate occlusal loading conditions are achieved.
- Ø3.3 mm implants are for replacing maxillary lateral incisors and mandibular incisors with delayed loading only.
- Ø5.0 mm and larger implants are intended for delayed loading in the molar region.
All digitally designed custom components (including Ti-Base and Pre-milled Blanks) for use with the DIMPLO Implant System are to be manufactured at a DIMPLO validated milling center.
The DIMPLO Implant System consists of fixtures, abutments, and attachments designed for dental implant procedures.
Fixture: Made of unalloyed titanium (Grade 4, ASTM F67), these dental implants are available in a range of diameters and lengths to accommodate various clinical applications in the maxilla and mandible. The surface is treated with SLA (Sandblasted, Large grit, and Acid-etched) and provided sterile via gamma irradiation. Available in two platform sizes: Mini and Regular.
Abutment: These components aid in prosthetic restorations. This category includes Cover Screws, Healing Abutments, Temporary Abutments, Cemented Abutments, Angled Abutments, Ti-Base, Pre-milled Blanks, Screws, Multi-unit Abutments, Healing Caps, and Cylinders.
Attachments: Includes Locatus Male Cap and Locatus Retention Male. The Locatus Male Cap is made of titanium alloy (Ti-6Al-4V ELI), while the Locatus Retention Male is made of nylon.
Fixtures and cover screws are supplied sterile. All other abutments and attachments are provided non-sterile and must be sterilized by the end user before use.
Ti-Base consists of a two-piece abutment that includes a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient-specific superstructure) at the top, composing the final abutment.
Superstructure and Bonding Materials
- Zirconia material: InCoris Zi (ZrO₂) (K123664, Sirona Dental Systems GmbH)
- Bonding agent: RelyX Unicem 2 Automix (K100756, 3M ESPE)
Design Envelope for Zirconia superstructure
| Dimensional Characteristics | Range/Limit |
|---|---|
| Post Angle (°) | 0~20 |
| Cuff Height (mm) | 0.5~5.0 |
| Abutment Post Height (mm) | 4.0~6.0 |
| Diameter (Ø , mm) | 5.0~8.0 |
| Wall Thickness (mm) | 0.4~ |
Design Envelope for Pre-milled Blank
| Dimensional Characteristics | Range/Limit |
|---|---|
| Post Angle (°) | 0~30 |
| Cuff Height (mm) | 0.5~6.0 |
| Abutment Post Height (mm) | 4.0~7.0 |
| Diameter (Ø , mm) | 3.5~6.5 |
| Wall Thickness (mm) | 0.4~ |
Note: Abutment Post Height is defined as the minimum cementable post height for single-unit restoration, measured as the height above the restorative margin.
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(454 days)
The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.
All digitally designed abutments for use with Warantec Custom Abutments are intended to be sent to a Warantec-validated milling center for manufacture.
Warantec Custom Abutments are used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. That is customized abutment considering shape of the final prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing. The Warantec Custom Abutment are made of Ti-6A1-4V ELI (ASTM F136). These devices are supplied non-sterile and autoclaved by the end user and intended for single use only. Warantec Custom Abutments are compatible with IU Implant System.
I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and the study that proves the device meets the acceptance criteria in the format you specified.
The document is a 510(k) summary for a dental abutment, primarily focusing on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use. It lists non-clinical testing data such as:
- Steam sterilization validation
- Biocompatibility of the material
- Fatigue testing according to ISO 14801:2016 and FDA Special Controls Guidance Document.
- Non-clinical worst-case MRI review.
However, it does not provide specific acceptance criteria values for these tests or reported device performance against those criteria in a tabular format. It also explicitly states: "No clinical data were included in this submission."
Therefore, I cannot extract details like:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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(223 days)
Dentium Ti-Base abutments are intended for use on Dentium endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.
All digitally designed abutments for use with Dentium Ti-Base abutments are intended to be sent to a Dentium-validated milling center for manufacture.
Dentium Ti-Base is a patient specific abutment fabricated by Dentium and composed of unalloyed titanium and zirconia ceramic. The Ti-Base has a titanium pre-manufactured precision abutment/implant interface and ceramic superstructure bonded to the post of the titanium base. Ti-Base is used for support of CAD/CAM fabricated zirconia superstructures or for support of hybrid crowns or bridges. Hybrid crowns or bridges and zirconia superstructures are manufactured by a Dentium validated milling center.
Ti-Base Abutments are available in two prosthetic diameters (4.5 and 5.5 mm) and four gingival heights (0.5, 1.0, 1.5, and 2.0 mm). Each of the abutments is available indexed and non-indexed. All subject device abutments are compatible with Dentium and Dentium Superline dental implants.
The provided text describes a 510(k) premarket notification for the Dentium Ti-Base dental abutment, establishing its substantial equivalence to previously marketed predicate devices. This type of submission relies on non-clinical performance data rather than extensive clinical studies with specific acceptance criteria as might be seen for novel devices.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Device Performance (Result) |
|---|---|
| Sterilization Validation | According to ISO 17665-2 to an SAL of 10⁻⁶ |
| Cytotoxicity | According to ISO 10993-5, determining the subject device is non-cytotoxic |
| Dynamic Compression-Bending Strength | According to ISO 14801, ensuring that the subject device is strong enough for its intended use (Specific values not provided) |
| Substantial Equivalence (Indications for Use) | Determined to be substantially equivalent to predicate devices (K150367, K161713) |
| Substantial Equivalence (Design, Function, Material, Manufacture) | Determined to be substantially equivalent to predicate devices, with minor differences in design dimensions and implant/abutment interface noted for K150367 and K161713. Materials are similar (Unalloyed Titanium ASTM F67, Zirconia ISO 13356). |
| Substantial Equivalence (Physical Dimensions) | Encompasses the same range of physical dimensions (diameter, gingival height, angle of abutments) as predicate devices. |
2. Sample Sizes and Data Provenance
- Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. For ISO 14801, typical sample sizes are small (e.g., n=5 or n=10 per test condition), but this is not specified.
- Data Provenance: The studies are non-clinical (laboratory/mechanical testing). The manufacturer is Dentium Co., Ltd. in the Republic of Korea. Therefore, the data originates from the manufacturer's testing or a contracted testing facility. All data is presumably prospective as it was generated to support the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- This information is not applicable as the studies are non-clinical performance tests for a device seeking substantial equivalence, not a diagnostic algorithm requiring expert-established ground truth. The "ground truth" for these tests is defined by the standards (ISO 17665-2, ISO 10993-5, ISO 14801).
4. Adjudication Method for the Test Set
- This information is not applicable as the studies are non-clinical performance tests and do not involve human adjudication for a "test set" in the context of diagnostic assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical dental abutment, not a diagnostic AI system that would assist human readers.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. The device is a physical medical device. The "digitally designed abutments" mentioned refer to CAD/CAM processes used in manufacturing, but this is a manufacturing method, not an AI algorithm requiring standalone performance evaluation in the medical sense.
7. Type of Ground Truth Used
- The "ground truth" applied here is primarily established international standards for medical device testing (e.g., ISO 17665-2 for sterilization, ISO 10993-5 for cytotoxicity, ISO 14801 for mechanical strength). For substantial equivalence, the performance is compared against the characteristics of legally marketed predicate devices.
8. Sample Size for the Training Set
- This information is not applicable. The device is a physical product, not an AI/ML algorithm that is "trained" on a dataset. The manufacturing process might involve CAD/CAM software, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no "training set" in the context of an AI/ML algorithm.
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