The following data is part of a premarket notification filed by Essential Dental Systems, Inc. with the FDA for Eds Combo-rinse.
| Device ID | K140846 |
| 510k Number | K140846 |
| Device Name: | EDS COMBO-RINSE |
| Classification | Cleanser, Root Canal |
| 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 | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-07-25 |
| Summary: | summary |