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510(k) K140125

NEW STETIC DENTAL AMALGAM ALLOY by New Stetic — Product Code OIV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2014
Date Received
January 16, 2014
Clearance Type
Traditional
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

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  • K122925 — NEW STETIC ARTIFICIAL TEETH (February 12, 2013)
  • K102874 — NEW STETIC ACRYLICS (March 28, 2011)

Other clearances for product code OIV

  • K223182 — Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 (May 1, 2023)
  • K081273 — ULTRACAPS S (July 10, 2008)