(129 days)
Class I to Class V restorations Core build up
The subject Surefil one™ Self-adhesive Composite Hybrid is an self- adhesive dental restorative material which is intended to be used as a restorative filling material for direct restorations. The "composite hybrid" composition of the subject device is based on resin-modified glass ionomer chemistry and is provided in a powder/liquid formulation in a mixing capsule.
The subject Surefil one™ Self-adhesive Composite Hybrid offers is available in multiple shades and exhibits the following features:
- Self-adhesiveness to enamel and dentin
- Fluoride release
- Bulk fill and dual-cure
- Radiopacity (equivalent to 2mm aluminum).
The provided text describes the Dentsply Sirona Surefil one™ Self-adhesive Composite Hybrid, a dental restorative material, and its substantial equivalence determination by the FDA based on non-clinical performance data.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for each test. Instead, it states that the performance "satisfactorily met the requirements" and that the device "conforms to the requirements" of the standards. The reported device performance is presented as meeting these standards.
| Test Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Data | Complies with ISO 9917-2:2017 and internal Dentsply Sirona criteria. | |
| Compressive strength | Satisfactorily met requirements | Met requirements |
| Flexural strength | Satisfactorily met requirements | Met requirements |
| Setting time | Satisfactorily met requirements | Met requirements |
| Radio-opacity | Satisfactorily met requirements | Met requirements |
| Shear bond strength to enamel | Satisfactorily met requirements | Met requirements |
| Shear bond strength to dentin | Satisfactorily met requirements | Met requirements |
| Shear bond strength to composite | Satisfactorily met requirements | Met requirements |
| Enamel wear (including ACTA wear test) | Satisfactorily met requirements | Met requirements |
| Biocompatibility | Complies with EN ISO 10993-1. | |
| Cytotoxicity testing | Satisfactorily met requirements | Met requirements |
| Chemical analysis of leachable organic and inorganic compounds | Satisfactorily met requirements | Met requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "In-vitro bench tests were performed" and "Comparartive tests were performed between the proposed Surefil one™ Self-adhesive Composite Hybrid and the predicate device (K130223)". However, the specific sample sizes used for each test are not provided in this document. The data provenance is described as non-clinical in-vitro bench tests conducted by Dentsply Sirona, referencing ISO 9917-2:2017 and EN ISO 10993-1. There is no information about country of origin of the data beyond "internal Dentsply Sirona criteria". The data is prospective for the purpose of this submission (i.e., new tests were performed).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this study involves non-clinical in-vitro bench testing of physical and chemical properties of a dental restorative material, the concept of "experts used to establish ground truth" as it would apply to diagnostic imaging or clinical decisions is not directly applicable. The "ground truth" for these tests is based on established international standards (ISO, EN ISO) and internal company criteria, which are derived from scientific principles and industry best practices for material characterization. No information on human experts establishing ground truth for these in-vitro tests is provided.
4. Adjudication Method for the Test Set
As explained above, since the study involves non-clinical in-vitro bench testing, an adjudication method for human-read interpretations is not applicable or mentioned. The results of these tests are objective measurements against predefined criteria/standards.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical bench study comparing the physical and chemical properties of the device against a predicate and established standards, not an evaluation of human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone study was done in the sense that the device's performance was evaluated independently through in-vitro bench tests. This refers to the algorithm/device itself (the dental material in this case) and its intrinsic properties, without human-in-the-loop performance measurement.
7. Type of Ground Truth Used
The ground truth used for the non-clinical tests is based on scientific measurement against established international standards (e.g., ISO 9917-2:2017, EN ISO 10993-1) and internal Dentsply Sirona criteria. This is essentially an objective, measured characteristic rather than an expert consensus, pathology, or outcomes data in the traditional medical device sense.
8. Sample Size for the Training Set
This document describes a premarket notification for a physical medical device (dental restorative material), not an AI/ML-driven device that requires training data. Therefore, the concept of a "training set" and its sample size is not applicable to this submission.
9. How the Ground Truth for the Training Set Was Established
As stated above, a training set is not applicable to this type of device.
§ 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.