(64 days)
The KaVo Everest® C-temp is used in the manufacture of temporary dental prosthetics to be worn 12 months or less.
The KaVo Everest® C-temp is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
The provided 510(k) summary for the KaVo Everest® C-temp material primarily focuses on demonstrating substantial equivalence to predicate devices based on formulation, intended use, and general material classification rather than presenting a study for device performance against specific acceptance criteria. This class II dental material is evaluated through biocompatibility testing and standard compliance rather than a diagnostic performance study. As such, many of the requested categories related to medical device performance studies (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable or explicitly stated in this type of submission.
Below is an attempt to structure the available information as per your request, with explicit notes where information is not provided or not applicable due to the nature of the device and its regulatory submission.
Acceptance Criteria and Device Performance Study for KaVo Everest® C-temp
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Conformance |
|---|---|---|---|
| Biocompatibility | Compatibility with long-term contact to human mucous membranes. | "Biocompatibility testing has been conducted to show compatibility with long term contact to human mucous membranes." | Met |
| Material Classification | Identification as "Material, tooth shade, resin" under 21 CFR 872.3690. | The device is classified as "Material, tooth shade, resin 21 CFR 872.3690 Class II medical device" and is found substantially equivalent to predicate devices and the IDENTIFICATION of tooth shade, resins in 21 CFR 872.3690. The FDA's final classification is "21 CFR 872.3770 Temporary Crown and Bridge Resin". | Met |
| Standard Compliance | Meets requirements of DIN IEC 60893. | "Meets the requirements of DIN IEC 60893" | Met |
| Substantial Equivalence | Demonstrates substantial equivalence to legally marketed predicate devices (KaVo Everest® ZS K032081 and Austenal DC-Tell K001799) based on formulation and intended uses. | "The claim of substantial equivalence is based on comparisons of formulations and intended uses of the KaVo devices to legally marketed predicates... Based on the information in the notification KaVo America believes that The KaVo Everest® C-temp is substantially equivalent to cited legally marketed predicates..." FDA confirmed substantial equivalence. | Met |
| Intended Use | For manufacture of temporary dental prosthetics to be worn 12 months or less. | The indication for use is precisely "The KaVo Everest® C-temp is used in the manufacture of temporary dental prosthetics to be worn 12 months or less." This aligns with the specified intended use for substantial equivalence. | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable/Not Provided: This submission focuses on material properties, biocompatibility, and substantial equivalence to legally marketed predicate devices rather than a diagnostic performance study with a test set of data samples. The "test set" in this context would refer to material samples used for the specified laboratory tests (biocompatibility, DIN IEC 60893 compliance), but specific sample sizes are not detailed in the summary. Data provenance would be from laboratory testing procedures by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable: For a dental material cleared via substantial equivalence, ground truth as established by clinical experts for a diagnostic performance study is not relevant here. The "truth" is established by laboratory testing standards and comparison to predicate devices, verified by regulatory bodies.
4. Adjudication Method for the Test Set
- Not Applicable: As there is no diagnostic test set requiring human interpretation and consensus, no adjudication method (e.g., 2+1, 3+1) is relevant.
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 submission for a dental material, not an AI-assisted diagnostic device. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- Not Applicable: This is a dental material, not a standalone algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the KaVo Everest® C-temp is established by:
- Laboratory Testing Results: Demonstrating biocompatibility and conformance to the DIN IEC 60893 standard.
- Material Composition/Formulation: Comparison of the material's constituents to predicate devices deemed safe and effective.
- Intended Use Alignment: Confirming the proposed use case (temporary dental prosthetics for 12 months or less) aligns with predicate devices and regulatory definitions.
- Regulatory Classification: Conforming to the established classification for "Temporary Crown and Bridge Resin" (21 CFR 872.3770).
8. The Sample Size for the Training Set
- Not Applicable/Not Provided: This is not an AI/machine learning device that would require a "training set." The development process for a dental material would involve R&D and testing, but not in the context of a training algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set for an algorithm, this question is not relevant.
§ 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.