The following data is part of a premarket notification filed by Essential Dental Systems, Inc. with the FDA for Ti-core Flow.
| Device ID | K101504 |
| 510k Number | K101504 |
| Device Name: | TI-CORE FLOW |
| 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 | 2010-06-01 |
| Decision Date | 2010-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766054000204 | K101504 | 000 |
| 00766054000198 | K101504 | 000 |
| 00766054000051 | K101504 | 000 |
| 00766054000044 | K101504 | 000 |