Cleared Traditional

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. · Dental

Jul 2024

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K240707 is an FDA 510(k) clearance for the 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), a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Shenzhen Micro Electric Intelligence Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 2, 2024, 109 days after receiving the submission on March 15, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number	K240707 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2024
Decision Date	July 02, 2024
Days to Decision	109 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF