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510(k) K040043

NDX-40 ALLOY by Heraeus Kulzer, Inc. — Product Code EJT

K040043 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, Inc. for the device "NDX-40 ALLOY". The FDA issued a decision of Substantially Equivalent on Mar 3, 2004. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Heraeus Kulzer, Inc. has 165 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 3, 2004
Date Received
Jan 12, 2004
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
510(k) Exempt

Other clearances by Heraeus Kulzer, Inc.

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  • K123278 — IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF… (Dec 7, 2012)
  • K120914 — FLEXITIME FAST & SCAN LIGHT FLOW (Jul 25, 2012)
  • K113574 — FLEXITIME MONOPHASE PRO SCAN (Jul 13, 2012)
  • K112501 — VENUS PEARL PLT REFILL A1 (Dec 14, 2011)
  • K111832 — PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID (Sep 29, 2011)
  • K110037 — PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID (Apr 29, 2011)
  • K102770 — FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST &… (Dec 21, 2010)
  • K101617 — FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY… (Sep 7, 2010)
  • K093575 — GLUMA DESENSITIZER POWER GEL (Mar 5, 2010)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (Oct 14, 2005)
  • K041378 — BIO 60 (Aug 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C… (Mar 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (Jan 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (Nov 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (Nov 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (Oct 1, 2003)
  • K032319 — CERA R PLUS ALLOY (Sep 30, 2003)

FDA data resources