Ultrasonic Scaler Tips

FDA 510(k) K230641 · Guilin Refine Medical Instrument Co., Ltd.

Substantially Equivalent

510(k) numberK230641

Submission

Device name
Ultrasonic Scaler Tips
Applicant
Guilin Refine Medical Instrument Co., Ltd.
Guilin, CN
Received
March 8, 2023
Decision date
November 21, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ELC – Scaler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4850
Specialty
Dental

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Questions and answers

When was Ultrasonic Scaler Tips cleared by the FDA?

Ultrasonic Scaler Tips (K230641) received a 510(k) decision of Substantially Equivalent on November 21, 2023, 258 days after the submission was received.

What is the product code of K230641?

The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.