The following data is part of a premarket notification filed by Essential Dental Systems, Inc. with the FDA for Ez-fill Xpress Epoxy Root Canal Cement System.
| Device ID | K063856 |
| 510k Number | K063856 |
| Device Name: | EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM |
| Classification | Resin, Root Canal Filling |
| Applicant | ESSENTIAL DENTAL SYSTEMS, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk ESSENTIAL DENTAL SYSTEMS, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-28 |
| Decision Date | 2007-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766054000181 | K063856 | 000 |
| 00766054000174 | K063856 | 000 |
| 00766054000167 | K063856 | 000 |