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510(k) K971138

DINABASE (TM) by Sultan Chemists, Inc. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1997
Date Received
March 28, 1997
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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  • K043054 — GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL (February 18, 2005)
  • K030414 — GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL (April 9, 2003)
  • 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)
  • 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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  • K250489 — FP3D (May 20, 2025)
  • K250617 — Apex Flex (April 29, 2025)
  • K243356 — Asiga DentaBASE (April 11, 2025)