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510(k) K052699

VERSA-LINK PORCELAIN BONDING SYSTEM by Sultan Chemists, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2005
Date Received
September 28, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

Other clearances by Sultan Chemists, Inc.

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  • 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)
  • K896826 — SULTAN PERIO-SELECT IRRIGATION SYSTEM (March 2, 1990)

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