Ultrasonic Scaler Tips
K-Number: K230641 · 2023-11-21
Decision Date2023-11-21
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Ultrasonic Scaler Tips is a medical device manufactured by Guilin Refine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under approval number K230641. 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 Ultrasonic Scaler Tips?
Ultrasonic Scaler Tips is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Guilin Refine Medical Instrument Co., Ltd.. The 510(k) number is K230641.
When was Ultrasonic Scaler Tips approved by the FDA?
Ultrasonic Scaler Tips received FDA 510(k) clearance on 2023-11-21, under approval number K230641.
What company makes Ultrasonic Scaler Tips?
Ultrasonic Scaler Tips is manufactured by Guilin Refine Medical Instrument Co., Ltd..
What is the FDA product code for Ultrasonic Scaler Tips?
The FDA product code for Ultrasonic Scaler Tips is ELC.
Other Devices by Guilin Refine Medical Instrument Co., Ltd.
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.