Medical Device Manufacturer · US , Westford , MA

Sultan Chemists, Inc.

11 submissions · 10 cleared · Since 1990
11
Total
10
Cleared
0
Denied

Sultan Chemists, Inc. — FDA 510(k) Submissions

Sultan Chemists, Inc. has submitted 11 FDA 510(k) premarket notifications since 1990, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Impression, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, Resin, Denture, Relining, Repairing, Rebasing, Disinfectant, Medical Devices, Cement, Dental . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
VERSA-LINK PORCELAIN BONDING SYSTEM
K052699 · KLE Agent, Tooth Bonding, Resin · Dental
Nov 2005 49d
SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
K052409 · ELW Material, Impression · Dental
Oct 2005 49d
GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
K043054 · ELW Material, Impression · Dental
Feb 2005 105d
GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
K030414 · ELW Material, Impression · Dental
Apr 2003 61d
SULTAN SPOROX TEST VIAL, MODEL 75195
K020612 · JOJ Indicator,... · General Hospital
May 2002 71d
SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010
K002843 · EMA Cement, Dental · Dental
Nov 2000 64d
PRO-PORTION CLEANER/DISINFECTANT
K991509 · LRJ Disinfectant, Medical... · General Hospital
Jul 1999 75d
DINABASE (TM)
K971138 · EBI Resin, Denture, Relining,... · Dental
Jul 1997 115d
ASSURE, SELF-SEALING STERILIZATION POUCH
K951590 · KCT Sterilization Wrap... · General Hospital
May 1995 41d
ASSURE SELF SEALING STERILIZATION POUCH
K933729 · KCT Sterilization Wrap... · General Hospital
Jun 1994 323d
SULTAN PERIO-SELECT IRRIGATION SYSTEM
K896826 · Dental
Mar 1990 88d
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