The following data is part of a premarket notification filed by Mavrik Dental Systems Ltd with the FDA for Armor Lc.
Device ID | K182118 |
510k Number | K182118 |
Device Name: | Armor LC |
Classification | Dam, Rubber |
Applicant | Mavrik Dental Systems Ltd 25 Ha Haroshet Street, 6th Floor Raanana, IL |
Contact | Sherwyn Davidson |
Correspondent | Sherwyn Davidson Heyer Regulatory Solutions LLC 25 Ha Haroshet Street 6th Fl. Raanana, IL 4365613 |
Product Code | EIE |
CFR Regulation Number | 872.6300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-06 |
Decision Date | 2019-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ARMOR LC 88012310 not registered Live/Pending |
Mavrik Dental Systems Ltd 2018-06-23 |