Aquasil Ultra + Smart Wetting Impression Material
K-Number: K152861 · 2016-03-04
ApplicantDentply International, Inc.
Decision Date2016-03-04
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Aquasil Ultra + Smart Wetting Impression Material is a medical device manufactured by Dentply International, Inc.. It received FDA 510(k) clearance on 2016-03-04 under approval number K152861. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aquasil Ultra + Smart Wetting Impression Material?
Aquasil Ultra + Smart Wetting Impression Material is a medical device that received FDA 510(k) clearance on 2016-03-04. It is manufactured by Dentply International, Inc.. The 510(k) number is K152861.
When was Aquasil Ultra + Smart Wetting Impression Material approved by the FDA?
Aquasil Ultra + Smart Wetting Impression Material received FDA 510(k) clearance on 2016-03-04, under approval number K152861.
What company makes Aquasil Ultra + Smart Wetting Impression Material?
Aquasil Ultra + Smart Wetting Impression Material is manufactured by Dentply International, Inc..
What is the FDA product code for Aquasil Ultra + Smart Wetting Impression Material?
The FDA product code for Aquasil Ultra + Smart Wetting Impression Material is ELW.
Related Devices (Code: ELW)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.