TEMPOARY POLYCARBONATE CROWNS
Device Facts
| Record ID | K932759 |
|---|---|
| Device Name | TEMPOARY POLYCARBONATE CROWNS |
| Applicant | South American Dental Exporting Corp. |
| Product Code | ELZ · Dental |
| Decision Date | Jul 22, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3330 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A preformed crown is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be affixed temporarily to a tooth after removal of, or breakage of, the natural crown (that portion of the tooth that normally protrudes above the gums). It is intended for use as a functional restoration until a permanent crown is constructed. The device also may be intended for use as a functional restoration for a badly decayed deciduous (baby) tooth until the adult tooth erupts.
