(133 days)
[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of prosthetic restorations on implant abutments and frames
[3] Cementation of adhesion bridges and splints
[4] Cementation of posts and cores
[5] Amalgam bonding
The subject device is a dual-cure (light- and/or self-cure), fluoride releasing, radiopaque self-adhesive resin cement for ceramic (porcelain, lithium disilicate, zirconia, etc.), composite resin, and metal restorations. It is supplied in an automix delivery system which can mix equal amounts of two components.
The provided text describes the regulatory clearance of a dental cement, PANAVIA SA Cement Plus Automix, and establishes its substantial equivalence to predicate devices, primarily PANAVIA SA CEMENT Automix and PANAVIA F 2.0. The "study" referenced in the text is a set of non-clinical tests performed to demonstrate this equivalence, rather than a clinical study involving human patients.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials) for physical and mechanical properties, and ISO/TS 11405: 2003 for shear bond strengths.
| Acceptance Criteria (Standard / Test) | Subject Device Performance (PANAVIA SA Cement Plus Automix) | Predicate Device Performance (PANAVIA SA CEMENT Automix / PANAVIA F 2.0) |
|---|---|---|
| ISO 4049: 2009 Performance | ||
| 5.2.2 Film thickness, luting materials | COMPLIES | COMPLIES |
| 5.2.4 Working time, Class 1 and Class 3 luting materials | COMPLIES | COMPLIES |
| 5.2.6 Setting time, Class 3 materials | COMPLIES | COMPLIES |
| 5.2.9 Flexural strength | COMPLIES | COMPLIES |
| 5.2.10 Water sorption and solubility | COMPLIES | COMPLIES |
| 5.4 Color stability after irradiation and water sorption | COMPLIES | COMPLIES |
| 5.5 Radio-opacity | COMPLIES | COMPLIES |
| ISO/TS 11405: 2003 Shear Bond Strength | ||
| Adherend surface: Tooth dentin (In-house standard criteria) | COMPLIES | COMPLIES |
| Adherend surface: Tooth enamel (In-house standard criteria) | COMPLIES | COMPLIES |
| Adherend surface: Ceramic (In-house standard criteria) | COMPLIES | COMPLIES |
| Adherend surface: Metal (In-house standard criteria) | COMPLIES | COMPLIES |
| Adherend surface: Titan (In-house standard criteria) | COMPLIES | COMPLIES |
| Adherend surface: Composite resin (In-house standard criteria) | COMPLIES | COMPLIES |
| Adherend surface: Amalgam (In-house standard criteria) | COMPLIES | COMPLIES |
| Released fluorine ion test | Substantially equivalent to predicate device | Baseline for comparison |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test or the "test set" in the context of clinical data. The studies are non-clinical, laboratory-based tests. The data provenance is not explicitly stated as country of origin, but the submitting company is Kuraray Noritake Dental Inc. located in Japan and the tests refer to international standards (ISO). The studies are retrospective in the sense that they are laboratory evaluations performed for regulatory submission, not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies are non-clinical laboratory tests. "Ground truth" in this context refers to established standards and physical measurements, not expert interpretation of clinical images or data.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are non-clinical laboratory tests. Adjudication methods (like 2+1, 3+1) are typically used for establishing consensus among human readers in clinical studies.
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 performed. This is a non-clinical evaluation of a dental cement, not an AI or imaging diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a "standalone" performance study in the context of an algorithm or AI was not done. The device is a dental cement, not a software or AI product. The performance studies describe the material properties in a laboratory setting.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluations (physical, mechanical, and bond strength tests) are the established requirements and methodologies of international standards (ISO 4049: 2009 and ISO/TS 11405: 2003) as well as in-house standards for shear bond strength criteria. For biocompatibility, it refers to the requirements of ISO 10993 series and ISO 7405. These are objective, quantitative measurements and adherence to established protocols.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable for this type of non-clinical device evaluation. Training sets are used in machine learning for AI model development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set mentioned or implied in the context of this device's evaluation.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.