EzDent-i / E2 / Prora View
K-Number: K161117 · 2016-05-13
ApplicantEwoosoft Co., Ltd.
Decision Date2016-05-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EzDent-i / E2 / Prora View is a medical device manufactured by Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2016-05-13 under approval number K161117. 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 / Prora View?
EzDent-i / E2 / Prora View is a medical device that received FDA 510(k) clearance on 2016-05-13. It is manufactured by Ewoosoft Co., Ltd.. The 510(k) number is K161117.
When was EzDent-i / E2 / Prora View approved by the FDA?
EzDent-i / E2 / Prora View received FDA 510(k) clearance on 2016-05-13, under approval number K161117.
What company makes EzDent-i / E2 / Prora View?
EzDent-i / E2 / Prora View is manufactured by Ewoosoft Co., Ltd..
What is the FDA product code for EzDent-i / E2 / Prora View?
The FDA product code for EzDent-i / E2 / Prora View 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.