INJECT-R FILL
Device Facts
| Record ID | K931742 |
|---|---|
| Device Name | INJECT-R FILL |
| Applicant | Union Broach, Div. Moyco Industries, Inc. |
| Product Code | EKM · Dental |
| Decision Date | May 27, 1993 |
| 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.
