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510(k) K093587

DENTAL MERCURY by Dmg USA, Inc. — Product Code ELY

K093587 is an FDA 510(k) premarket notification submitted by Dmg USA, Inc. for the device "DENTAL MERCURY". The FDA issued a decision of Substantially Equivalent on January 21, 2010. The device falls under product code ELY (Mercury), a Class II device regulated under 21 CFR 872.3070. Dmg USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2010
Date Received
November 19, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Dmg USA, Inc.

  • K171772 — Ecosite Bulk Fill (January 31, 2018)
  • K160443 — TempoCem Clear (September 30, 2016)
  • K130580 — RETRACTION PASTE (February 25, 2014)
  • K110759 — TEMPOCEM (June 10, 2011)
  • K102603 — SA FLOWABLE ADHESIVE (November 17, 2010)
  • K101710 — LUXATEMP ULTRA /STAR (September 28, 2010)
  • K100062 — INFILTRATION KIT (March 26, 2010)
  • K093338 — SELF ADHESIVE COMPOSITE LUTING CEMENT (February 12, 2010)
  • K081493 — INFILTRATION KIT (September 18, 2008)
  • K080480 — NANOCOMPOSITE RESTORATIVE KIT (May 30, 2008)

Other clearances for product code ELY

  • K973548 — MERCURY DENTAL (March 23, 1998)
  • K913814 — MODEL #05 ANEROID SPHYGMOMANOMETER KIT (January 16, 1992)
  • K902388 — DENTAL-QUECKSILBER (DENTAL MERCURY) (June 28, 1990)

FDA data resources