VarseoSmile Temp
K-Number: K193553 · 2020-05-18
Decision Date2020-05-18
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
VarseoSmile Temp is a medical device manufactured by Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG. It received FDA 510(k) clearance on 2020-05-18 under approval number K193553. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VarseoSmile Temp?
VarseoSmile Temp is a medical device that received FDA 510(k) clearance on 2020-05-18. It is manufactured by Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG. The 510(k) number is K193553.
When was VarseoSmile Temp approved by the FDA?
VarseoSmile Temp received FDA 510(k) clearance on 2020-05-18, under approval number K193553.
What company makes VarseoSmile Temp?
VarseoSmile Temp is manufactured by Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG.
What is the FDA product code for VarseoSmile Temp?
The FDA product code for VarseoSmile Temp is EBG.
Related Devices (Code: EBG)
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.