EVO 450 series High Speed Handpieces
K-Number: K190508 · 2019-12-11
ApplicantTtbio Corp.
Decision Date2019-12-11
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EVO 450 series High Speed Handpieces is a medical device manufactured by Ttbio Corp.. It received FDA 510(k) clearance on 2019-12-11 under approval number K190508. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EVO 450 series High Speed Handpieces?
EVO 450 series High Speed Handpieces is a medical device that received FDA 510(k) clearance on 2019-12-11. It is manufactured by Ttbio Corp.. The 510(k) number is K190508.
When was EVO 450 series High Speed Handpieces approved by the FDA?
EVO 450 series High Speed Handpieces received FDA 510(k) clearance on 2019-12-11, under approval number K190508.
What company makes EVO 450 series High Speed Handpieces?
EVO 450 series High Speed Handpieces is manufactured by Ttbio Corp..
What is the FDA product code for EVO 450 series High Speed Handpieces?
The FDA product code for EVO 450 series High Speed Handpieces is EFB.
Related Clinical Trials
Other Devices by Ttbio Corp.
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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.