(89 days)
Estar-ZE is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges.
Estar-ZE is a ceramic intended to manufacture dental restorations, including inlays, artificial teeth, crowns and bridges.
Estar-ZE is prefabricated ceramic block (pre-sintered yttrium-stabilized zirconium oxide) which is to be milled and sintered in the furnace to produce the final dental restorations. After sintering, it forms polycrytstalline oxide ceramic consisted of Tetragonal Zirconium Oxide Polycrystal (TZP). In accordance with ISO 6872:2015, it is classified as Type II Class 5 zirconia.
Estar-ZE is provided in non-sterile and available in various shades and thickness of disk shape and block shape
Here's a breakdown of the acceptance criteria and study information for the Estar-ZE device, based on the provided FDA 510(k) summary:
Device: Estar-ZE (Porcelain Powder for Clinical Use)
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Material Type | ISO 6872:2015 Classification | Type II Class 5 zirconia |
| Flexural Strength | >800 MPa | >800 MPa |
| Biocompatibility | ISO 10993 standards | Meets requirements |
Study Proving Device Meets Acceptance Criteria:
The provided document describes non-clinical performance testing to demonstrate substantial equivalence of the Estar-ZE device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for the mechanical properties or biocompatibility testing. It only states that the device was "designed and tested" and that "all tests have passed the evaluation criteria."
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin specified for the test data itself (although the manufacturer is based in Korea).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the device is a ceramic material and the testing described is non-clinical (mechanical properties, biocompatibility), not involving human diagnostic interpretation or ground truth established by experts.
4. Adjudication Method
This information is not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed. This type of study is typically relevant for AI/software devices where human readers provide diagnoses or interpretations.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not performed. This is also relevant for AI/software devices. The Estar-ZE is a physical dental material.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on established international standards:
- ISO 6872:2015 Dentistry - Ceramic Materials for mechanical properties (e.g., flexural strength, classification).
- ISO 10993 suite of standards for biocompatibility.
8. Sample Size for the Training Set
This information is not applicable. The Estar-ZE is a physical ceramic material, not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 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.