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510(k) Data Aggregation
(118 days)
DD Bio Z, DD Bio ZX(square), DD BioZX(square) color
DD Bio Z-dental blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
Dental milling blanks made of DD Bio Z, DD Bio ZX 2 , DD Bio ZX 2 color are semi-finished products out of yttrium-stabilized, pre-sintered zirconium dioxide for the fabrication of crown- and bridge- frameworks on commercial CAD/CAM systems or hand-operated copy-milling machines, with outstanding biocompatibility and mechanical properties.
This document, a 510(k) submission for dental milling blanks (DD Bio Z, DD Bio ZX2, DD Bio ZX2 color), focuses on demonstrating substantial equivalence to a predicate device (K093748: DD Bio Z, DD Bio Z transpa) rather than establishing novel safety and effectiveness through a comprehensive study with acceptance criteria.
Therefore, many of the requested categories are not applicable or not explicitly stated in this type of regulatory document. I will fill in the available information and explicitly state when information is not provided.
Acceptance Criteria and Device Performance for DD Bio Z, DD Bio ZX2, DD Bio ZX2 color
This submission is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to a legally marketed predicate device, as opposed to proving de novo safety and effectiveness through clinical trials with defined acceptance criteria. The primary method of demonstrating equivalence here is through non-clinical testing to voluntary design standards and comparison of material properties.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the typical sense of a clinical study endpoint. Instead, it relies on conformance to a voluntary design standard (ISO 6872:2008) and comparison of key material properties to the predicate and to the intended use. The performance reported below focuses on the material specifications as compared to the predicate.
| Characteristic | Acceptance Criteria (based on ISO 6872:2008 or predicate specs) | Reported Device Performance (DD Bio Z / DD Bio ZX2) | Notes |
|---|---|---|---|
| Biocompatibility | Conformance to DIN EN ISO 10993-1, 10993-5 (cytotoxicity) | Passed specified biocompatibility tests | "DD Bio Z zirconia was tested by an accredited testing laboratory regarding cytotoxicity (according to DIN EN ISO 10993-5) and biological compatibility (according to DIN EN ISO 10993-1)." Chemical analysis for contaminants was also done. The document states, "Based on the established use of the identical material in cleared devices, and on testing of the materials to the biocompatibility requirements of design standard ISO 6872:2008, additional biocompatibility testing is not considered necessary." |
| Chemical composition | Equivalent to predicate (allowing for minor improvements) | ZrO2 + HfO2 + Y2O3: Same as predicate | |
| Y2O3: Same as predicate | |||
| Al2O3: DD Bio Z: = predicate (DD Bio Z: 1000 ± 200 MPa) | DD Bio Z / DD Bio ZX2: 1200 ± 200 MPa | The reported flexural strength for DD Bio Z / DD Bio ZX2 (1200 ± 200 MPa) is higher than the predicate DD Bio Z (1000 ± 200 MPa) and the original DD Bio Z transpa. This is presented as an improvement due to the increased Alumina content in DD Bio ZX2. The document states: "The increase of Alumina content in the raw material as used for DD Bio ZX2 compared to the predicate DD Bio Z transpa leads to an increase in flexural strength." | |
| Risk Management | Adherence to ISO 14971 | Device designed to eliminate or mitigate known health hazards as per ISO 14971 | The device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program according to ISO 14971 "Medical devices - Application of risk management to medical devices". |
| Material Group | Stay the same (3Y-TZP) | Stayed the same (3Y-TZP) | "The material group 3Y-TZP for the products in this submission and the predicate submission stayed the same." |
| Intended Use | Identical to predicate | "for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges." | "All ceramic zirconia products incorporates the same intended use with the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in terms of number of devices/cases tested for each specific property. The submission refers to "testing of the materials to the biocompatibility requirements of design standard ISO 6872:2008" and "non-clinical testing... to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary design standard: ISO 6872:2008." The specific methodology or sample sizes for these tests are not provided in this summary.
- Data Provenance: Not specified in the provided summary. However, the submitter is "Dental Direkt of Amerika UG (haftungsbeschraenkt)" located in Germany, suggesting testing may have been conducted there or by affiliated accredited laboratories.
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)
Not applicable. This is a material science and biocompatibility assessment, not a diagnostic imaging study requiring expert interpretation for "ground truth." The "truth" is established by laboratory measurements against defined standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human adjudication process described, as this is related to material properties and biocompatibility testing against objective 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
Not applicable. This device is a dental milling blank (a material), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the material properties and biocompatibility is established by:
- Physical and Chemical Measurements: Laboratory tests against established material science parameters (e.g., flexural strength, chemical composition).
- Standard Conformance: Adherence to recognized international standards such as DIN EN ISO 10993-1, ISO 10993-5 (biocompatibility), and ISO 6872:2008 (dental ceramic specifications).
8. The sample size for the training set
Not applicable. This device is a physical material, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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