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510(k) K973548

MERCURY DENTAL by Aleaciones Dentales Zeyco, S.A. DE C.V. — Product Code ELY

K973548 is an FDA 510(k) premarket notification submitted by Aleaciones Dentales Zeyco, S.A. DE C.V. for the device "MERCURY DENTAL". The FDA issued a decision of Substantially Equivalent on March 23, 1998. The device falls under product code ELY (Mercury), a Class II device regulated under 21 CFR 872.3070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1998
Date Received
September 18, 1997
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 for product code ELY

  • K093587 — DENTAL MERCURY (January 21, 2010)
  • K913814 — MODEL #05 ANEROID SPHYGMOMANOMETER KIT (January 16, 1992)
  • K902388 — DENTAL-QUECKSILBER (DENTAL MERCURY) (June 28, 1990)

FDA data resources