EzDent-i / E2 / Prora View
K号: K190087 · 2019-02-27
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器械摘要
EzDent-i / E2 / Prora View is the device name listed in this FDA 510(k) record. The listed applicant is Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2019-02-27 under 510(k) number K190087. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EzDent-i / E2 / Prora View?
EzDent-i / E2 / Prora View is a medical device that received FDA 510(k) clearance on 2019-02-27. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K190087.
When did EzDent-i / E2 / Prora View receive FDA 510(k) clearance?
EzDent-i / E2 / Prora View received FDA 510(k) clearance on 2019-02-27, under 510(k) number K190087.
Who is the listed applicant for EzDent-i / E2 / Prora View?
The FDA 510(k) record lists Ewoosoft Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EzDent-i / E2 / Prora View?
The FDA product code for EzDent-i / E2 / Prora View is LLZ.
相关临床试验
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列明Ewoosoft Co., Ltd.为申报人的其他记录
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相关器械（代码：LLZ）
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官方来源
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