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510(k) K012835

PORTA MAXIMUM, MODEL# 2066 by Wieland Edelmetalle GmbH & Co. — Product Code EJT

K012835 is an FDA 510(k) premarket notification submitted by Wieland Edelmetalle GmbH & Co. for the device "PORTA MAXIMUM, MODEL# 2066". The FDA issued a decision of Substantially Equivalent on November 1, 2001. 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
November 1, 2001
Date Received
August 23, 2001
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)
  • 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)
  • 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 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