The following data is part of a premarket notification filed by Essential Dental Systems, Inc with the FDA for Eds Universal Cement.
| Device ID | K152691 |
| 510k Number | K152691 |
| Device Name: | EDS Universal Cement |
| Classification | Cement, Dental |
| Applicant | ESSENTIAL DENTAL SYSTEMS, INC 89 LEUNING STREET, SUITE 8 South Hackensack, NJ 07606 |
| Contact | Jeffrey Wan |
| Correspondent | Jeffrey Wan ESSENTIAL DENTAL SYSTEMS, INC 89 LEUNING STREET, SUITE 8 South Hackensack, NJ 07606 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2016-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766054000334 | K152691 | 000 |
| 00766054000327 | K152691 | 000 |
| 00766054000310 | K152691 | 000 |