FDA Medical Device Definition: 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.
FDA Gutta-Percha Label Requirements and Exceptions
FDA Gutta-Percha Import Information
FDA Gutta-Percha Detentions (Gutta-Percha Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Gutta-Percha Manufacturers (Gutta-Percha Suppliers)
- Gutta-Percha Distributors
- Gutta-Percha Processors
- Gutta-Percha Repackers
- Gutta-Percha Relabelers
- Gutta-Percha Exporters
- Gutta-Percha Importers
For more information about Gutta-Percha Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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