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510(k) K896826

SULTAN PERIO-SELECT IRRIGATION SYSTEM by Sultan Chemists, Inc.

K896826 is an FDA 510(k) premarket notification submitted by Sultan Chemists, Inc. for the device "SULTAN PERIO-SELECT IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 2, 1990. Sultan Chemists, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 2, 1990
Date Received
December 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Sultan Chemists, Inc.

  • K052699 — VERSA-LINK PORCELAIN BONDING SYSTEM (November 16, 2005)
  • K052409 — SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL (October 20, 2005)
  • 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)
  • K971138 — DINABASE (TM) (July 21, 1997)
  • K951590 — ASSURE, SELF-SEALING STERILIZATION POUCH (May 17, 1995)
  • K933729 — ASSURE SELF SEALING STERILIZATION POUCH (June 21, 1994)

FDA data resources