BioSonic US200 Ultrasonic Scaler (60034537)
K-Number: K240801 · 2024-07-01
ApplicantDent4you AG
Decision Date2024-07-01
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BioSonic US200 Ultrasonic Scaler (60034537) is a medical device manufactured by Dent4you AG. It received FDA 510(k) clearance on 2024-07-01 under approval number K240801. 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 BioSonic US200 Ultrasonic Scaler (60034537)?
BioSonic US200 Ultrasonic Scaler (60034537) is a medical device that received FDA 510(k) clearance on 2024-07-01. It is manufactured by Dent4you AG. The 510(k) number is K240801.
When was BioSonic US200 Ultrasonic Scaler (60034537) approved by the FDA?
BioSonic US200 Ultrasonic Scaler (60034537) received FDA 510(k) clearance on 2024-07-01, under approval number K240801.
What company makes BioSonic US200 Ultrasonic Scaler (60034537)?
BioSonic US200 Ultrasonic Scaler (60034537) is manufactured by Dent4you AG.
What is the FDA product code for BioSonic US200 Ultrasonic Scaler (60034537)?
The FDA product code for BioSonic US200 Ultrasonic Scaler (60034537) is ELC.
Other Devices by Dent4you AG
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.