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510(k) K001041

AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD by Wieland Edelmetalle GmbH & Co. — Product Code EJT

K001041 is an FDA 510(k) premarket notification submitted by Wieland Edelmetalle GmbH & Co. for the device "AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD". The FDA issued a decision of Substantially Equivalent on May 23, 2000. The device falls under product code EJT (Alloy, Gold-Based 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
May 23, 2000
Date Received
March 31, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based 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)
  • K012841 — DUO PAL 6, ORDER-NO.: 2154 (November 20, 2001)
  • K012843 — PORTADUR P 2, MODEL #2031 (November 2, 2001)
  • K012826 — BIOPORTA G, MODEL 2052 (November 1, 2001)
  • K012828 — PORTA SMK 82, MODEL 2032 (November 1, 2001)
  • K012835 — PORTA MAXIMUM, MODEL# 2066 (November 1, 2001)
  • K012834 — PORTA GEO TI MODEL #2004 (November 1, 2001)
  • K012831 — BIO PORTADUR, ORDER-NO.:2017 (November 1, 2001)
  • K012827 — PORTA AURIUM, MODEL 2067 (November 1, 2001)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)

FDA data resources