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510(k) K110037

PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID by Heraeus Kulzer, LLC — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2011
Date Received
January 6, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

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  • K120914 — FLEXITIME FAST & SCAN LIGHT FLOW (July 25, 2012)
  • K113574 — FLEXITIME MONOPHASE PRO SCAN (July 13, 2012)
  • K112501 — VENUS PEARL PLT REFILL A1 (December 14, 2011)
  • K111832 — PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID (September 29, 2011)
  • K102770 — FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCA (December 21, 2010)
  • K101617 — FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CAR (September 7, 2010)
  • K093575 — GLUMA DESENSITIZER POWER GEL (March 5, 2010)
  • K091635 — VENUS DIAMOND FLOW (September 3, 2009)

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