Aquasil Ultra Smart Wetting Impression Material
FDA 510(k) K113406 · Dentsply International, Inc.
510(k) numberK113406
Submission
- Device name
- Aquasil Ultra Smart Wetting Impression Material
- Applicant
- Dentsply International, Inc.
York, PA, US - Received
- November 18, 2011
- Decision date
- February 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Aquasil Ultra Smart Wetting Impression Material cleared by the FDA?
Aquasil Ultra Smart Wetting Impression Material (K113406) received a 510(k) decision of Substantially Equivalent on February 13, 2012, 87 days after the submission was received.
What is the product code of K113406?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.