Aquasil Ultra Monophase/Heavy/Lv Smart Wetting Impression Material
FDA 510(k) K021416 · Dentsply Intl.
510(k) numberK021416
Submission
- Device name
- Aquasil Ultra Monophase/Heavy/Lv Smart Wetting Impression Material
- Applicant
- Dentsply Intl.
York, PA, US - Received
- May 3, 2002
- Decision date
- May 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Aquasil Ultra Monophase/Heavy/Lv Smart Wetting Impression Material cleared by the FDA?
Aquasil Ultra Monophase/Heavy/Lv Smart Wetting Impression Material (K021416) received a 510(k) decision of Substantially Equivalent on May 13, 2002, 10 days after the submission was received.
What is the product code of K021416?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.