Cleared Traditional

K242317 - Integrated Endo System (Meet Endo-II)

K242317 is an FDA 510(k) clearance for Integrated Endo System (Meet Endo-II), manufactured by Denjoy Dental Co., Ltd.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K242317 · Denjoy Dental Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
192d
Days
Class 2
Risk

K242317 is an FDA 510(k) clearance for the Integrated Endo System (Meet Endo-II). Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Denjoy Dental Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on February 13, 2025 after a review of 192 days - an extended review cycle.

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 Denjoy Dental Co., Ltd. devices

FDA 510(k) Submission Details - K242317

510(k) Number K242317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2024
Decision Date February 13, 2025
Days to Decision 192 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
65d slower than avg
Panel avg: 127d · This submission: 192d
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 78
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