The following data is part of a premarket notification filed by South American Dental Exporting Corp. with the FDA for Tempoary Polycarbonate Crowns.
| Device ID | K932759 |
| 510k Number | K932759 |
| Device Name: | TEMPOARY POLYCARBONATE CROWNS |
| Classification | Crown, Preformed |
| Applicant | SOUTH AMERICAN DENTAL EXPORTING CORP. 1058 EAST 33RD ST. Hialeah, FL 33013 |
| Contact | Lopez |
| Correspondent | Lopez SOUTH AMERICAN DENTAL EXPORTING CORP. 1058 EAST 33RD ST. Hialeah, FL 33013 |
| Product Code | ELZ |
| CFR Regulation Number | 872.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-08 |
| Decision Date | 1994-07-22 |