ENDO-CHX
Cleanser, Root Canal
ESSENTIAL DENTAL SYSTEMS, INC.
The following data is part of a premarket notification filed by Essential Dental Systems, Inc. with the FDA for Endo-chx.
Pre-market Notification Details
| Device ID | K070401 |
| 510k Number | K070401 |
| Device Name: | ENDO-CHX |
| Classification | Cleanser, Root Canal |
| Applicant | ESSENTIAL DENTAL SYSTEMS, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan Goldstein-falk |
| Correspondent | Susan Goldstein-falk ESSENTIAL DENTAL SYSTEMS, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-02-12 |
| Decision Date | 2007-07-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766054000099 | K070401 | 000 |
Trademark Results [ENDO-CHX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDO-CHX 78778921 not registered Dead/Abandoned |
Essential Dental Systems, Inc. 2005-12-22 |
 ENDO-CHX 77331654 3440533 Live/Registered |
Essential Dental Systems, Inc. 2007-11-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.