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510(k) K031264

PORTA PRESSOVER by Wieland Dental + Technik GmbH & Co. KG — Product Code EJT

K031264 is an FDA 510(k) premarket notification submitted by Wieland Dental + Technik GmbH & Co. KG for the device "PORTA PRESSOVER". The FDA issued a decision of Substantially Equivalent on June 12, 2003. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Wieland Dental + Technik GmbH & Co. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2003
Date Received
April 21, 2003
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 Dental + Technik GmbH & Co. KG

  • K152118 — Zenostar MT, Zenostar Color Liquids (December 16, 2015)
  • K151142 — IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID (August 13, 2015)
  • K142233 — zenostar MO, Zenostar T, Zenostar VisualiZr (January 5, 2015)
  • K130184 — ZENOLUX (May 24, 2013)
  • K112710 — ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR (October 17, 2011)
  • K103773 — ZENOFLEX DIMENSION (March 16, 2011)
  • K103494 — ZENOSTAR MAGIC GLAZE (February 16, 2011)
  • K082257 — ZENO AI ECO DISC (September 18, 2008)
  • K080182 — ZENO PMMA DISC (April 8, 2008)
  • K073108 — ZENO ZR DISC (November 21, 2007)

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