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510(k) K182118

armor LC by Mavrik Dental Systems, Ltd. — Product Code EIE

K182118 is an FDA 510(k) premarket notification submitted by Mavrik Dental Systems, Ltd. for the device "armor LC". The FDA issued a decision of Substantially Equivalent on May 3, 2019. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2019
Date Received
August 6, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dam, Rubber
Device Class
Class I
Regulation Number
872.6300
Review Panel
DE
Submission Type

Other clearances for product code EIE

  • K151945 — Triumph Resin Dam (February 18, 2016)
  • K050318 — BARI-KAD PACKING DEVICE (March 4, 2005)
  • K043301 — GC TION GINGIVAL PROTECTOR (January 25, 2005)
  • K040797 — BRITESMILE MASKING CREAM (April 2, 2004)
  • K022522 — PULPDENT PUTTY DAM (September 26, 2002)
  • K021524 — LIGHT CURE DENTAL DAM (July 19, 2002)
  • K021613 — NIVEOUS LIQUID DAM (June 20, 2002)
  • K010935 — BRITESMILE BARRIER MATERIAL (September 5, 2001)
  • K983227 — POWER BLOCK (December 11, 1998)
  • K972775 — FASTDAM (February 27, 1998)

FDA data resources