(120 days)
- Temporary cementation of crowns and bridges
- Provisional cementation of crowns and bridges on implant abutments
GC Fuji TEMP is a 2-paste type, glass ionomer provisional luting cement filled in separate syringes, and assembled in one cartridge. With use of Paste Pak Dispenser, GC Fuji TEMP can be dispensed with the appropriate paste ratio.
Here's a breakdown of the acceptance criteria and study information for the GC Fuji Temp device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Standards / Requirements | Reported Device Performance |
|---|---|---|
| Appearance | • Free from extraneous material • Homogeneous and smoothly consistent (ISO 9917-1: 2007) | Within spec set by standard |
| Film thickness | Less than 25µm (ISO 3107: 2004) | Within spec set by standard |
| Setting time | 4 to 10 min (ISO 3107: 2004) | Within spec set by standard |
| Compressive strength | Less than 35MPa (ISO 3107: 2004) | Within spec set by standard |
| Acid-soluble lead content (1st test) | Less than 0.40mm (ISO 9917-1: 2007) | Within spec set by standard |
| Acid-soluble lead content (2nd test) | Less than 100mg/kg (ISO 9917-1: 2007) | Within spec set by standard |
| Radiopacity | More than equivalent thickness of aluminum (ISO 9917-1: 2007) | Within spec set by standard |
| Working time | 2min30sec - 3min30sec (given by the manufacturer via Company Specification: AB-15-Q-301-493) | Within spec set by standard |
| Color | Equivalent to standard sample (given by the manufacturer via Company Specification: AB-15-Q-301-493) | Within spec set by standard |
| Consistency | 27 – 37 mm (given by the manufacturer via Company Specification: AB-15-Q-301-493) | Within spec set by standard |
2. Sample Size Used for the Test Set and Data Provenance
The sample sizes for the test set vary by property:
- Appearance: Visual inspection (no specific N given, but implied for each paste before/after mixing).
- Film thickness: N=5
- Setting time: N=2
- Compressive strength: N=5
- Acid-soluble lead content (first test): N=5
- Acid-soluble lead content (second test): N=1
- Radiopacity: N=1
- Working time: Not explicitly stated, derived from "mixed cement becomes rubbery."
- Color: Not explicitly stated, derived from "Comparing set cement with standard sample."
- Consistency: Not explicitly stated, but 0.5 mL of mixed cement is loaded.
Data Provenance: The document does not explicitly state the country of origin. It appears to be an internal company study ("Company Specification: AB-15-Q-301-493" and "Company Specification AB-15-Q-301-493" are mentioned). The study is retrospective in the sense that the results are presented as already obtained and summarized for FDA submission; it's a report of testing, not a protocol for future prospective testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests are based on engineering standards (ISO) and company specifications, which rely on measurable physical properties rather than expert interpretation of data.
4. Adjudication Method for the Test Set
This information is not applicable as the tests performed are objective physical property measurements, not subjective evaluations that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data. This device is a dental cement, and its evaluation focuses on physical and chemical properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance tests of the dental cement itself, without any human-in-the-loop component. The "device" in this context is the physical cement, not a digital algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for these tests are the established requirements and specifications set forth by international standards (ISO) and company internal specifications. These standards define acceptable ranges for physical and chemical properties (e.g., film thickness, setting time, compressive strength, acid-soluble lead content, radiopacity, working time, color, consistency).
8. The Sample Size for the Training Set
This information is not applicable/not provided. The product is a physical dental cement, not a machine learning model, so there is no "training set" in the conventional sense. The "training" for the product would be the formulation and material science development, but this document focuses on final product testing.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the reasons stated above.
§ 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.