The following data is part of a premarket notification filed by Synapse Dental with the FDA for Dental Pain Eraser.
Device ID | K193570 |
510k Number | K193570 |
Device Name: | Dental Pain Eraser |
Classification | Device, Electrical Dental Anesthesia |
Applicant | Synapse Dental 67 Phenix Avenue Cranston, RI 02920 |
Contact | Cosmo Haralambidis |
Correspondent | Valerie Defiesta-ng Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 |
Product Code | LWM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-23 |
Decision Date | 2020-01-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DENTAL PAIN ERASER 87587652 5885907 Live/Registered |
Haralambidis, Cosmo 2017-08-29 |