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510(k) Data Aggregation
(89 days)
United Zirconia
ZircaGlow & ZircaGlow HT Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
ZircaGlow & ZircaGlow HT Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as a crown, bridge or coping.
The provided FDA 510(k) clearance letter details a dental product (zirconia blanks) and its substantial equivalence to a predicate device, rather than a medical device that utilizes artificial intelligence or machine learning. Therefore, many of the requested criteria related to AI/ML device performance (e.g., ground truth, expert adjudication, MRMC studies, effect size of AI assistance, training set details) are not applicable or cannot be extracted from this document.
However, I can provide information based on the physical and chemical properties and the nonclinical testing performed to establish substantial equivalence.
Acceptance Criteria and Device Performance for ZircaGlow & ZircaGlow HT Zirconia
The device is a dental material (zirconia blanks) and its performance is evaluated against material properties and compliance with industry standards, comparing it to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for ZircaGlow & ZircaGlow HT Zirconia are primarily based on meeting or exceeding the requirements of established international standards (ISO 6872:2024 and ISO 13356:2015) for dental ceramic materials, and demonstrating similar performance characteristics to a predicate device.
| Property | Acceptance Criteria (ISO Standard Requirement / Predicate Similarity) | ZircaGlow Zirconia Performance | ZircaGlow HT Zirconia Performance | Predicate Device (ArgenZ HT+) Performance |
|---|---|---|---|---|
| Sintered Density | ≥ 6.0 g/cm³ (ISO 13356:2024 Sec 4.1) | ≥ 6.04 g/cm³ | ≥ 6.04 g/cm³ | 6.08 g/cm³ |
| Bending/Flexural Strength | > 800 MPa (ISO 6872:2024, Class 5) | White: ~1138 MPa | ||
| A4: ~1085 MPa | ||||
| C4: ~1058 MPa (>800 MPa) | White: ~963 MPa | |||
| A4: ~961 MPa | ||||
| C4: ~956 MPa (>800 MPa) | 1,348 MPa | |||
| Fracture Toughness (KIC) | ≥ 5.0 MPa√m (ISO 6872:2024 Annex A, minimum for Class 5) | White: 8.5 MPa√m | ||
| A4: 8.1 MPa√m | ||||
| C4: 8.3 MPa√m (>5.0 MPa√m) | White: 8.7 MPa√m | |||
| A4: 8.5 MPa√m | ||||
| C4: 8.4 MPa√m (>5.0 MPa√m) | Not supplied (but meets >5.0 MPa√m implicitly for Class 5) | |||
| Chemical Solubility | 99 wt% (Similar to predicate) | > 99.9 wt% | > 99.9 wt% | > 99 wt% |
| Biocompatibility | Compliant with ISO 10993-1:2018 | Assured through use of same materials and manufacturing processes as predicate devices | Assured through use of same materials and manufacturing processes as predicate devices | Tested for Cytotoxicity on shaded material, no adverse reactions identified |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for the mechanical and chemical property tests. The data provenance is derived from nonclinical testing performed by United Zirconia on their ZircaGlow and ZircaGlow HT Zirconia blanks. The location of the testing is not specified, but the applicant's address is Cairo, Egypt. This testing is prospective in the sense that the manufacturer specifically conducted these tests to demonstrate compliance for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the tests are for material properties, not for diagnostic or predictive performance requiring human expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for material properties testing. The values are determined by standardized laboratory methods.
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 is a dental material, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental material, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device is based on objective measurements of physical and chemical properties determined through standardized laboratory testing methods (e.g., ISO 6872:2024, ISO 13356:2015). This is not equivalent to expert consensus, pathology, or outcomes data used for diagnostic devices.
8. The sample size for the training set
Not applicable. This is a dental material, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a dental material, not a machine learning model. The relevant "truth" for the manufacturing process would be adherence to quality system regulations (21 CFR Part 820).
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