The following data is part of a premarket notification filed by Essential Dental Systems, Inc. with the FDA for Flexi-flow Cement Natural.
| Device ID | K922249 |
| 510k Number | K922249 |
| Device Name: | FLEXI-FLOW CEMENT NATURAL |
| Classification | Cement, Dental |
| Applicant | ESSENTIAL DENTAL SYSTEMS, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Anand Akerkar |
| Correspondent | Anand Akerkar ESSENTIAL DENTAL SYSTEMS, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-06 |
| Decision Date | 1994-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766054000242 | K922249 | 000 |
| 00766054000082 | K922249 | 000 |
| 00766054000075 | K922249 | 000 |