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510(k) K223182

Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy by Worldwork S.R.L — Product Code OIV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2023
Date Received
October 11, 2022
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dental Amalgam
Device Class
Class II
Regulation Number
872.3070
Review Panel
DE
Submission Type

Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth

Other clearances for product code OIV

  • K140125 — NEW STETIC DENTAL AMALGAM ALLOY (April 29, 2014)
  • K081273 — ULTRACAPS S (July 10, 2008)