Silgimix Alginate Replacement Impression Material
FDA 510(k) K052409 · Sultan Chemists, Inc.
510(k) numberK052409
Submission
- Device name
- Silgimix Alginate Replacement Impression Material
- Applicant
- Sultan Chemists, Inc.
Englewood, NJ, US - Received
- September 1, 2005
- Decision date
- October 20, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K030414 | Genie Ultra Hydrophilic Impression MaterialELW · Traditional | 04/09/2003SE |
| K020612 | Sultan Sporox Test Vial, Model 75195JOJ · Traditional | 05/07/2002SE |
| K002843 | Sultan Sensitemp Resin Temporary Cement, Model 70010EMA · Traditional | 11/15/2000SE |
| K991509 | Pro-Portion Cleaner/DisinfectantLRJ · Traditional | 07/14/1999SE |
| K971138 | Dinabase (TM)EBI · Traditional | 07/21/1997SE |
| K951590 | Assure, Self-Sealing Sterilization PouchKCT · Traditional | 05/17/1995SE |
| K933729 | Assure Self Sealing Sterilization PouchKCT · Traditional | 06/21/1994SE |
| K896826 | Sultan Perio-Select Irrigation System · Traditional | 03/02/1990SEKD |
Questions and answers
When was Silgimix Alginate Replacement Impression Material cleared by the FDA?
Silgimix Alginate Replacement Impression Material (K052409) received a 510(k) decision of Substantially Equivalent on October 20, 2005, 49 days after the submission was received.
What is the product code of K052409?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.