The following data is part of a premarket notification filed by Essential Dental Systems, Inc. with the FDA for Flexi-cast Crown Core System.
| Device ID | K896693 |
| 510k Number | K896693 |
| Device Name: | FLEXI-CAST CROWN CORE SYSTEM |
| Classification | Post, Root Canal |
| Applicant | ESSENTIAL DENTAL SYSTEMS, INC. 7 WEST 36TH ST. New York, NY 10018 |
| Contact | R Marshall,phd |
| Correspondent | R Marshall,phd ESSENTIAL DENTAL SYSTEMS, INC. 7 WEST 36TH ST. New York, NY 10018 |
| Product Code | ELR |
| CFR Regulation Number | 872.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-28 |
| Decision Date | 1990-02-14 |