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510(k) K012841

DUO PAL 6, ORDER-NO.: 2154 by Wieland Edelmetalle GmbH & Co. — Product Code EJS

K012841 is an FDA 510(k) premarket notification submitted by Wieland Edelmetalle GmbH & Co. for the device "DUO PAL 6, ORDER-NO.: 2154". The FDA issued a decision of Substantially Equivalent on November 20, 2001. The device falls under product code EJS (Alloy, Other Noble Metal), a Class II device regulated under 21 CFR 872.3060. Wieland Edelmetalle GmbH & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2001
Date Received
August 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Other Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by Wieland Edelmetalle GmbH & Co.

  • K020347 — AGC SPEZIALLEGIERUNG (April 24, 2002)
  • K012839 — AUROPAL, ORDER-NO.: 2101 (December 31, 2001)
  • K012843 — PORTADUR P 2, MODEL #2031 (November 2, 2001)
  • K012834 — PORTA GEO TI MODEL #2004 (November 1, 2001)
  • K012835 — PORTA MAXIMUM, MODEL# 2066 (November 1, 2001)
  • K012831 — BIO PORTADUR, ORDER-NO.:2017 (November 1, 2001)
  • K012827 — PORTA AURIUM, MODEL 2067 (November 1, 2001)
  • K012828 — PORTA SMK 82, MODEL 2032 (November 1, 2001)
  • K012826 — BIOPORTA G, MODEL 2052 (November 1, 2001)
  • K012838 — ERO50, ORDER-NO.: 2070 (October 23, 2001)

Other clearances for product code EJS

  • K041433 — BRIGHT GOLD XH (August 19, 2004)
  • K040436 — SIMIDUR SUPERIOR (March 5, 2004)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K022469 — ECO E4 (September 18, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020195 — SIMIDUR S1S (March 15, 2002)
  • K020194 — SIMIDUR KF PLUS (March 15, 2002)
  • K020192 — SIMIDUR S2 (March 15, 2002)
  • K014042 — D.SIGN 84 (February 22, 2002)
  • K013809 — D.SIGN 59 (February 7, 2002)

FDA data resources