EzDent-i; E2; ProraView
K-Number: K163533 · 2017-01-12
ApplicantEwoosoft Co., Ltd.
Decision Date2017-01-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EzDent-i; E2; ProraView is a medical device manufactured by Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2017-01-12 under approval number K163533. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EzDent-i; E2; ProraView?
EzDent-i; E2; ProraView is a medical device that received FDA 510(k) clearance on 2017-01-12. It is manufactured by Ewoosoft Co., Ltd.. The 510(k) number is K163533.
When was EzDent-i; E2; ProraView approved by the FDA?
EzDent-i; E2; ProraView received FDA 510(k) clearance on 2017-01-12, under approval number K163533.
What company makes EzDent-i; E2; ProraView?
EzDent-i; E2; ProraView is manufactured by Ewoosoft Co., Ltd..
What is the FDA product code for EzDent-i; E2; ProraView?
The FDA product code for EzDent-i; E2; ProraView is LLZ.
Other Devices by Ewoosoft Co., Ltd.
Related Devices (Code: LLZ)
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.