EDTA PLUS
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 Edta Plus.
Pre-market Notification Details
| Device ID | K072555 |
| 510k Number | K072555 |
| Device Name: | EDTA PLUS |
| Classification | Cleanser, Root Canal |
| Applicant | ESSENTIAL DENTAL SYSTEMS, INC. 89 LEUNING ST. SUITE 8 South Hackensack, NJ 07606 |
| Contact | Brian Rasimick |
| Correspondent | Brian Rasimick ESSENTIAL DENTAL SYSTEMS, INC. 89 LEUNING ST. 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 | 2007-09-10 |
| Decision Date | 2007-12-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766054000112 | K072555 | 000 |
Trademark Results [EDTA PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EDTA PLUS 77272750 3502799 Live/Registered |
Essential Dental Systems, Inc. 2007-09-06 |
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