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510(k) K902388

DENTAL-QUECKSILBER (DENTAL MERCURY) by Degussa AG — Product Code ELY

K902388 is an FDA 510(k) premarket notification submitted by Degussa AG for the device "DENTAL-QUECKSILBER (DENTAL MERCURY)". The FDA issued a decision of Substantially Equivalent on June 28, 1990. The device falls under product code ELY (Mercury), a Class II device regulated under 21 CFR 872.3070. Degussa AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1990
Date Received
May 30, 1990
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 Degussa AG

  • K973288 — STABILOR HN (November 19, 1997)
  • K972910 — PORS ON LITE (October 14, 1997)
  • K960256 — DEGUDENT LS (February 21, 1996)
  • K960226 — DG 88 (February 14, 1996)
  • K960104 — BIOCCLUS 4 (February 6, 1996)
  • K955465 — DEGUPRINT (December 28, 1995)
  • K955118 — DEGUBOND X-LITE PLUS (December 11, 1995)
  • K955027 — DEGUBOND X-LITE (December 1, 1995)
  • K953344 — DEGUBOND ULTRA (August 25, 1995)
  • K951789 — PALLIAG NF IV (June 14, 1995)

Other clearances for product code ELY

  • K093587 — DENTAL MERCURY (January 21, 2010)
  • K973548 — MERCURY DENTAL (March 23, 1998)
  • K913814 — MODEL #05 ANEROID SPHYGMOMANOMETER KIT (January 16, 1992)

FDA data resources