ENDO-PREP
Device Facts
| Record ID | K896663 |
|---|---|
| Device Name | ENDO-PREP |
| Applicant | Pulpdent Corp. |
| Product Code | EKM · Dental |
| Decision Date | Feb 14, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3850 |
| Device Class | Class 1 |
Regulatory Classification
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.
