(174 days)
This material is intended for use in dentistry as a base or cavity liner under permanent restorations and for temporary restorations to teeth as an interim measure to protect cavities before a permanent restoration can be completed.
These materials consist of a powder and liquid which, when mixed together, form a setting mass suitable for their intended use.
The provided documentation is a 510(k) Premarket Notification for the "Super-Dent Intermediate Restorative Material," a temporary dental cement. The submission aims to demonstrate substantial equivalence to a predicate device (Temporary Dental Cement; 510(k) number K895487).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a formal table of acceptance criteria with numerical targets. Instead, the "NON-CLINICAL DATA" section discusses the characteristics of the device in comparison to the predicate device. The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device.
| Characteristic | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Super-Dent Intermediate Restorative Material) |
|---|---|---|
| Setting Characteristics | Essentially identical to the predicate device at stipulated mixing ratios. | "The setting characteristics of these materials are essentially identical at the stipulated mixing ratios." |
| Compressive Strength | Comparable to the predicate device. (While not explicitly stated, a "slightly lower" performance would need to be justified and deemed acceptable for clinical use). | "The compressive strength of the subject device is slightly lower... than the predicate device." |
| Disintegration | Comparable to the predicate device. (Similar to compressive strength, a "slightly higher" performance would require justification for clinical acceptability). | "...and the disintegration slightly higher than the predicate device." |
| Mixing Ease | Not explicitly an "acceptance criterion" for performance, but presented as a beneficial characteristic that outweighs slight performance differences. | "The subject device is subjectively very much easier to mix which is an important advantage in surgery use." This ease of mixing is leveraged to justify the performance differences. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "the setting characteristics of these materials," "the compressive strength," and "the disintegration," implying that some tests were performed, but the number of samples or specimens used for these tests is not provided.
- Data Provenance: The document (specifically "NON-CLINICAL DATA") describes lab-based testing comparing the subject device to the predicate device. The location of these tests is not specified, but the applicant (S.S. White Manufacturing, Ltd.) is based in England, so it's plausible the tests were conducted there. The nature of the data is retrospective in the sense that it's a comparison to an existing predicate device, and the testing was likely performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable as this is a materials science evaluation, not a diagnostic or interventional device requiring humanexpert interpretation for ground truth. The "ground truth" for material properties is established through standardized laboratory testing methods.
4. Adjudication Method for the Test Set:
- Not applicable for a materials science evaluation. The results are from physical and chemical property tests, not expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No MRMC study was done. The device is a dental material, not an imaging or diagnostic device requiring human reader interpretation with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This is a dental material, not an algorithm or AI-powered device.
7. The Type of Ground Truth Used:
- The ground truth for the non-clinical data (setting characteristics, compressive strength, disintegration) is based on standardized laboratory testing methods for dental materials. These methods are designed to objectively measure physical and chemical properties. The comparison is made against the performance of a predicate device, which would have established its own performance characteristics through similar objective testing.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set. The "device" is a physical dental material.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set is used for 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.