Sultan Chemists, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Sultan Chemists, Inc.” (first 1990, latest 2005), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 71 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELW | Material, Impression | 3 | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
| LRJ | Disinfectant, Medical Devices | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (6)
- General Hospital (4)
Most recent Sultan Chemists, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052699 | VERSA-LINK PORCELAIN BONDING SYSTEM | KLE | 2005-11-16 | 49 |
| K052409 | SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL | ELW | 2005-10-20 | 49 |
| K043054 | GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL | ELW | 2005-02-18 | 105 |
| K030414 | GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL | ELW | 2003-04-09 | 61 |
| K020612 | SULTAN SPOROX TEST VIAL, MODEL 75195 | JOJ | 2002-05-07 | 71 |
| K002843 | SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 | EMA | 2000-11-15 | 64 |
| K991509 | PRO-PORTION CLEANER/DISINFECTANT | LRJ | 1999-07-14 | 75 |
| K971138 | DINABASE (TM) | EBI | 1997-07-21 | 115 |
| K951590 | ASSURE, SELF-SEALING STERILIZATION POUCH | KCT | 1995-05-17 | 41 |
| K933729 | ASSURE SELF SEALING STERILIZATION POUCH | KCT | 1994-06-21 | 323 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sultan Chemists, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sultan Dental Products, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sultan Chemists, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Sultan Chemists, Inc.” (first 1990, latest 2005), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sultan Chemists, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sultan Chemists, Inc. is 71 days.
Which FDA product codes appear under Sultan Chemists, Inc.?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 3); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 2); EBI (Resin, Denture, Relining, Repairing, Rebasing, 1).
Next steps
- See all 11 Sultan Chemists, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ELW, Sultan Chemists, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.