Cleared Traditional

Ultrasonic Scaler Tips

K230641 · Guilin Refine Medical Instrument Co., Ltd. · Dental
Nov 2023
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K230641 is an FDA 510(k) clearance for the Ultrasonic Scaler Tips, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Guilin Refine Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on November 21, 2023, 258 days after receiving the submission on March 8, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K230641 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2023
Decision Date November 21, 2023
Days to Decision 258 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELC — Scaler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4850

Similar Devices — ELC Scaler, Ultrasonic

All 194
Varios Combi Pro2
K260773 · Nakanishi, Inc. · Mar 2026
GBT Machine Airflow Prophylaxis Master
K253254 · E.M.S Electro Medical Systems S.A · Jan 2026
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)
K251689 · Nakanishi, Inc. · Sep 2025
Integrated Endo System (Meet Endo-II)
K242317 · Denjoy Dental Co., Ltd. · Feb 2025
OdneClean
K233844 · Odne AG · Aug 2024
Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
K240707 · Shenzhen Micro Electric Intelligence Co., Ltd. · Jul 2024