armor LC— 510(k) K182118

Substantially Equivalent

Mavrik Dental Systems, Ltd.

FDA 510(k) clearance K182118 for armor LC, Substantially Equivalent on 2019-05-03. Applicant: Mavrik Dental Systems, Ltd.. Device class: 1.

Clearance details

Applicant: Mavrik Dental Systems, Ltd.
Product code: Code EIE
Device class: Class 1
Regulation: 21 CFR 872.6300
Advisory panel: Dental
Date received: 2018-08-06
Decision date: 2019-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raanana, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIE

K151945 — Triumph Resin Dam2016-02-18
K050318 — BARI-KAD PACKING DEVICE2005-03-04
K043301 — GC TION GINGIVAL PROTECTOR2005-01-25
K040797 — BRITESMILE MASKING CREAM2004-04-02
K022522 — PULPDENT PUTTY DAM2002-09-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.