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510(k) K043054

GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL by Sultan Chemists, Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2005
Date Received
November 5, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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  • K020612 — SULTAN SPOROX TEST VIAL, MODEL 75195 (May 7, 2002)
  • K002843 — SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 (November 15, 2000)
  • K991509 — PRO-PORTION CLEANER/DISINFECTANT (July 14, 1999)
  • K971138 — DINABASE (TM) (July 21, 1997)
  • K951590 — ASSURE, SELF-SEALING STERILIZATION POUCH (May 17, 1995)
  • K933729 — ASSURE SELF SEALING STERILIZATION POUCH (June 21, 1994)
  • K896826 — SULTAN PERIO-SELECT IRRIGATION SYSTEM (March 2, 1990)

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