Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sultan Chemists, Inc. · Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

71 daysmedian FDA review time
115 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K052699VERSA-LINK PORCELAIN BONDING SYSTEMSultan Chemists, Inc.2005-11-16490
K052409SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIALSultan Chemists, Inc.2005-10-20490
K043054GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIALSultan Chemists, Inc.2005-02-181050
K030414GENIE ULTRA HYDROPHILIC IMPRESSION MATERIALSultan Chemists, Inc.2003-04-09610
K020612SULTAN SPOROX TEST VIAL, MODEL 75195Sultan Chemists, Inc.2002-05-07710
K002843SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010Sultan Chemists, Inc.2000-11-15640
K991509PRO-PORTION CLEANER/DISINFECTANTSultan Chemists, Inc.1999-07-14750
K971138DINABASE (TM)Sultan Chemists, Inc.1997-07-211150
K951590ASSURE, SELF-SEALING STERILIZATION POUCHSultan Chemists, Inc.1995-05-17410
K933729ASSURE SELF SEALING STERILIZATION POUCHSultan Chemists, Inc.1994-06-213230
K896826SULTAN PERIO-SELECT IRRIGATION SYSTEMSultan Chemists, Inc.1990-03-02880

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda