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 |