(194 days)
White Peaks Copra Temp is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.
White Peaks Copra Temp is a device made from high quality 100% PMMA (polymethylmethacrylate) and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Two (2) pontics are allowed between two (2) abutment teeth. Restorations are designed using CAD technology and uses scans or models for the basis of the restoration to be milled. Copra Temp Blanks are available in a variety of thicknesses for different milling systems and are also available in a variety of Vita shades.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Copra Temp device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices (Zeno PMMA Disc and BRIGHTGLASS Discs) through material properties and intended use. The key performance metric highlighted is flexural strength.
| Acceptance Criteria / Performance Metric | Reported Device Performance (Copra Temp) | Predicate Device (BRIGHTGLASS) Performance | Predicate Device (ZENO PMMA) Performance |
|---|---|---|---|
| Flexural Strength (MPA) | 113 MPA | 106 MPA | 105 MPA |
| Material Composition | PMMA | PMMA | PMMA |
| Intended Use | Temporary crowns and bridges, up to 6 months in oral cavity | Temporary crowns and bridges, up to 6 months in oral cavity | Temporary crowns and bridges, up to 6 months in oral cavity |
| Device Class | Class II | Class II | Class II |
| Manufacturing Method (CAD/milling) | Designed with CAD, milled | Designed with CAM, milled | Designed with ZENO Tech system, milled |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a clinical performance study. The data presented for flexural strength is from pre-clinical testing.
- Sample Size: Not explicitly stated for flexural strength testing, but it would have been part of the pre-clinical testing mentioned.
- Data Provenance: The testing was "pre-clinical," implying laboratory or bench testing rather than human subject data. The country of origin for the data is implicitly Germany, where White Peaks Dental Systems GmbH & Co. KG is located. The data is retrospective in that it's reported from completed tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the submission describes pre-clinical material testing, not a clinical study involving expert assessment of patient outcomes or images. The "ground truth" for flexural strength would be the measured value according to established ISO standards.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a material (temporary crown and bridge resin), not an imaging or diagnostic device that typically involves human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm-only performance study was not done. This device is a physical material, not an algorithm or software.
7. The Type of Ground Truth Used
The ground truth used for the reported performance (flexural strength) was objective measurement according to recognized international standards. The document states:
- "Pre-clinical testing was performed to determine the physical properties of Copra Temp and for Biocompatibility and the tests passed per the requirements of ISO:10477, ISO:10993-1, ISO: 10993-3, ISO: 10993-5 and ISO:10993-10."
- ISO 10477: Dental polymer-based crown and veneering materials (likely where flexural strength methods are derived).
- The other ISO standards relate to biocompatibility, not direct performance comparison for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI/ML device or software. The device itself is a material for fabrication.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.