Sultan Sensitemp Resin Temporary Cement, Model 70010
FDA 510(k) K002843 · Sultan Chemists, Inc.
510(k) numberK002843
Submission
- Device name
- Sultan Sensitemp Resin Temporary Cement, Model 70010
- Applicant
- Sultan Chemists, Inc.
Kansas City, MO, US - Received
- September 12, 2000
- Decision date
- November 15, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Sultan Sensitemp Resin Temporary Cement, Model 70010 cleared by the FDA?
Sultan Sensitemp Resin Temporary Cement, Model 70010 (K002843) received a 510(k) decision of Substantially Equivalent on November 15, 2000, 64 days after the submission was received.
What is the product code of K002843?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.