iCTmotor (WL-1)
K-Number: K193341 · 2020-09-04
ApplicantDentium Co., Ltd.
Decision Date2020-09-04
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
iCTmotor (WL-1) is a medical device manufactured by Dentium Co., Ltd.. It received FDA 510(k) clearance on 2020-09-04 under approval number K193341. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iCTmotor (WL-1)?
iCTmotor (WL-1) is a medical device that received FDA 510(k) clearance on 2020-09-04. It is manufactured by Dentium Co., Ltd.. The 510(k) number is K193341.
When was iCTmotor (WL-1) approved by the FDA?
iCTmotor (WL-1) received FDA 510(k) clearance on 2020-09-04, under approval number K193341.
What company makes iCTmotor (WL-1)?
iCTmotor (WL-1) is manufactured by Dentium Co., Ltd..
What is the FDA product code for iCTmotor (WL-1)?
The FDA product code for iCTmotor (WL-1) is EBW.
Other Devices by Dentium Co., Ltd.
Related Devices (Code: EBW)
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.