(122 days)
"Dental Zirconia Blank for Aesthetic Restoration" is mainly used in prosthetic treatment. When the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is between 300-500 MPa, the product can be used for veneering, inlay, single crown, and substructure ceramic for three-unit prostheses not involving molar restoration; when the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is over 500 MPa, it can be used for veneering, inlay, single crown, and substrate ceramic for three-unit prostheses. All blanks are processed through dental laboratories or by dental professionals.
"Dental Zirconia Blank for Aesthetic Restoration" is derived from zirconia powder that has been processed through various molding and sintering techniques – into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO2 + Y2 O3 + HfO2+ Fe2O3+ Er2O3+ Al2O3. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"Dental Zirconia Blank for Aesthetic Restoration" is ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
"Dental Zirconia Blank for Aesthetic Restoration" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of forty-six different colors, three different translucencies, and two different aesthetic effects (single and multilayer).
The different colors are originated from the different constituent of color additives (such as Fe203, Er202); the different translucencies are originated from small difference in the amount of Y2 O3, and the different aesthetic effects are originated from the different padding method used in the process of dry pressing.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Dental Zirconia Blank for Aesthetic Restoration":
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel acceptance criteria for a new type of device. The acceptance criteria are largely based on adherence to existing ISO standards for dental ceramic materials and biocompatibility.
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Conformance to ISO 6872:2008 (Dentistry, Ceramic Materials) | "All tests were verified to meet acceptance criteria." |
| "Radioactivity" comparability | "very similar to the predicate device." | |
| "Pre-sintered density" comparability | "very similar to the predicate device." | |
| "Sintered density" comparability | "very similar to the predicate device." | |
| "Flexural strength" comparability | "very similar to the predicate device." | |
| Biocompatibility | Conformance to ISO 10993 (various parts) | "Results met all relevant requirements in the test standards, and are comparable to the predicate device." |
| Cytotoxicity (ISO 10993-5:2009) | No cytotoxicity effect | "No cytotoxicity effect" |
| Irritation Oral Mucosa (ISO 10993-10:2010) | Not a primary oral mucosa irritant | "Not a primary oral mucosa irritant under the conditions of the study" |
| Sensitization (ISO 10993-10:2010) | Not a sensitizer | "Not a sensitizer under the conditions of the study" |
| Subacute and Subchronic Toxicity (ISO 10993-11:2006) | No subchronic toxic effects observed | "No subchronic toxic effects observed" |
| Genotoxicity (ISO 10993-3:2003) | No genotoxic effects observed | "No genotoxic effects observed" |
| Overall Performance | Meets requirements per ISO 6872 and ISO 10993-1 | "Its performance meets the requirements of its pre-defined acceptance criteria and intended uses." |
| Comparable to predicate device | "The test results are also comparable to the predicate device." |
2. Sample Sizes used for the test set and the data provenance:
- Sample Size for Test Set: The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many specimens for flexural strength, how many animals for biocompatibility tests). It refers to "Bench testing" performed "per ISO 6872:2008 and internal procedures" and "Biocompatibility testing" performed "following the recommended procedures outlined in the FDA recognized consensus standard of ISO 10993." These ISO standards typically specify minimum sample sizes for material testing.
- Data Provenance: The studies were conducted by Liaoning Upcera Co., Ltd. for their "Dental Zirconia Blank for Aesthetic Restoration." The country of origin for the studies is implicitly China, as the submitter is based in Benxi, Liaoning, China. The studies are prospective in the sense that they were performed on the subject device to demonstrate compliance with standards and equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the document. The tests performed are objective, laboratory-based material characterization and biocompatibility assessments, not subjective evaluations requiring expert consensus for ground truth. The "ground truth" here is adherence to established international standards (ISO).
4. Adjudication method for the test set:
Not applicable. The tests are scientific measurements and biological evaluations, not requiring human adjudication.
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 material science and biocompatibility study for a dental restorative material, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a material science and biocompatibility study, not an algorithm.
7. The type of ground truth used:
The "ground truth" used for this device's acceptance is based on:
- International Standards: Primarily ISO 6872:2008 for ceramic materials and ISO 10993 series for biological evaluation of medical devices.
- Predicate Device Performance: The device's performance is explicitly compared against a legally marketed predicate device (K093560, "Upcera Zirconia Blanks") to establish substantial equivalence.
8. The sample size for the training set:
Not applicable. There is no machine learning or AI component described in this device submission, so the concept of a "training set" is irrelevant.
9. How the ground truth for the training set was established:
Not applicable, as no training set is involved.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.