# K182118: armor LC

- Pathway: 510(k) (Traditional)
- Applicant: Mavrik Dental Systems, Ltd.
- Decided: May 3, 2019 after 270 days
- Product code: EIE (Dam, Rubber)
- Device class: 1
- Regulation: 21 CFR 872.6300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971284 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151945: Triumph Resin Dam, Denali Corporation (2016) Summary page 4.

## Indications for use
armor LC™ is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.

Source page: https://510kreport.com/device/K182118
Methodology: https://510kreport.com/methodology
