The following data is part of a premarket notification filed by Svenska Dental Instruments Ab with the FDA for Sdi Polycarbonate Crown, Schein's.
| Device ID | K892893 |
| 510k Number | K892893 |
| Device Name: | SDI POLYCARBONATE CROWN, SCHEIN'S |
| Classification | Crown, Preformed |
| Applicant | SVENSKA DENTAL INSTRUMENTS AB P.O. BOX 1432 S-171 27 SOLNA Sweden, SE |
| Contact | Jannie Walker |
| Correspondent | Jannie Walker SVENSKA DENTAL INSTRUMENTS AB P.O. BOX 1432 S-171 27 SOLNA Sweden, SE |
| Product Code | ELZ |
| CFR Regulation Number | 872.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-20 |
| Decision Date | 1989-06-06 |