Cleared Traditional

K240707 - Ultrasonic Scaler (WD-JY-B002

K240707 is an FDA 510(k) clearance for Ultrasonic Scaler (WD-JY-B002, manufactured by Shenzhen Micro Electric Intelligence Co., Ltd.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K240707 · Shenzhen Micro Electric Intelligence Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
109d
Days
Class 2
Risk

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-.... Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Shenzhen Micro Electric Intelligence Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 2, 2024 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Micro Electric Intelligence Co., Ltd. devices

FDA 510(k) Submission Details - K240707

510(k) Number K240707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 127d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 74
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