Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

armor LC

K-Number: K182118 · 2019-05-03

ApplicantMavrik Dental Systems, Ltd.
Decision Date2019-05-03
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

armor LC is the device name listed in this FDA 510(k) record. The listed applicant is Mavrik Dental Systems, Ltd.. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K182118. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the armor LC?

armor LC is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Mavrik Dental Systems, Ltd.. The 510(k) number is K182118.

When did armor LC receive FDA 510(k) clearance?

armor LC received FDA 510(k) clearance on 2019-05-03, under 510(k) number K182118.

Who is the listed applicant for armor LC?

The FDA 510(k) record lists Mavrik Dental Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for armor LC?

The FDA product code for armor LC is EIE.

Related Devices (Code: EIE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K151945Triumph Resin DamDenali Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑