(131 days)
Fiberfill SGP is a root canal filling thermal plastic composite material used for endodontic therapy to fill the root canal of a tooth in replacing conventional Gutta Percha material.
Fiberfill SGP is a root canal filling thermal plastic composite material.
This document is an FDA letter regarding the clearance of a medical device, Fiberfill™ SGP, as substantially equivalent to a predicate device. It does not contain information about acceptance criteria, device performance, or any studies using AI. The letter is a regulatory approval document and not a scientific study report.
Therefore, I cannot provide the requested information based on the provided text. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance.
- Results of a standalone algorithm study.
- Type of ground truth used in a study.
- Sample size for a training set.
- How ground truth for a training set was established.
§ 872.3850 Gutta percha.
(a)
Identification. Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.(b)
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 the limitations in § 872.9.