(389 days)
Self-curing glass ionomer based radiopaque filling cement, for dental use only. Recommended Indications:
(1) Restoration of primary teeth.
(2) Restorations of Class III, V and limited Class I cavities.
(3) Base linings under composite and amalgam.
(4) Core build-up.
Glass Ionomer Cement (Filling) has two types: Filling II. It is a device composed of various materials including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as a permanent or temporary tooth filling or as base linings. It's a powder liquid system. The basic operation principle of Glass Ionomer Cement (Filling) is acid-base reaction.
The provided document describes the acceptance criteria and the study (physical and chemical properties tests) for the "Glass Ionomer Cement (Filling)" device (K160345).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria (Standard Requirement - ISO 9917-1:2007) | Reported Device Performance (Conclusion) |
|---|---|---|
| Components | Liquid: Free from deposits or filaments, no visible signs of gelation. Powder: Free from extraneous material, uniformly dispersed pigment (if colored). Unset cement: Homogeneous and smooth consistency. | Within spec set by standard |
| Net setting time | For restoration: 1.5~6 min | Within spec set by standard |
| Compressive strength | For restoration: ≥100 MPa | Within spec set by standard |
| Acid erosion | ≤0.17 mm | Within spec set by standard |
| Acid-soluble Lead content | ≤100 mg/kg | Within spec set by standard |
| Radio-opacity | At least equivalent to that for the same thickness of aluminum. | Within spec set by standard |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for each physical and chemical properties test. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that it refers to ISO standards and a submission by a Chinese company, it's highly probable the testing was conducted in a laboratory in China following international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the study described is a series of laboratory-based physical and chemical properties tests against predefined ISO standards, not a clinical study involving human assessment or interpretation requiring expert ground truth establishment.
4. Adjudication method for the test set
This section is not applicable as the study described is a series of laboratory-based physical and chemical properties tests against predefined ISO standards. There is no mention of adjudication for these types of tests.
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
This section is not applicable. The document describes a traditional device clearance for a dental material (Glass Ionomer Cement), not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical dental material, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria in this context is established by the ISO 9917-1:2007 standard for Dentistry — Water-based cements - Part 1: Powder/liquid acid-base cements. The reported performance is a direct measurement against these internationally recognized physical and chemical property specifications.
8. The sample size for the training set
This section is not applicable as the device is a physical dental material and not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 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.