TTBIO EVOCLEAN Ultrasonic Scaler
K-Number: K201317 · 2020-12-04
ApplicantTtbio Corp.
Decision Date2020-12-04
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TTBIO EVOCLEAN Ultrasonic Scaler is a medical device manufactured by Ttbio Corp.. It received FDA 510(k) clearance on 2020-12-04 under approval number K201317. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TTBIO EVOCLEAN Ultrasonic Scaler?
TTBIO EVOCLEAN Ultrasonic Scaler is a medical device that received FDA 510(k) clearance on 2020-12-04. It is manufactured by Ttbio Corp.. The 510(k) number is K201317.
When was TTBIO EVOCLEAN Ultrasonic Scaler approved by the FDA?
TTBIO EVOCLEAN Ultrasonic Scaler received FDA 510(k) clearance on 2020-12-04, under approval number K201317.
What company makes TTBIO EVOCLEAN Ultrasonic Scaler?
TTBIO EVOCLEAN Ultrasonic Scaler is manufactured by Ttbio Corp..
What is the FDA product code for TTBIO EVOCLEAN Ultrasonic Scaler?
The FDA product code for TTBIO EVOCLEAN Ultrasonic Scaler is ELC.
Other Devices by Ttbio Corp.
Related Devices (Code: ELC)
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.