Cleared Traditional

K040396 - ULTRASONIC SCALER ELEGANCE MS-10 (25K)

K040396 is an FDA 510(k) clearance for ULTRASONIC SCALER ELEGANCE MS-10 (25K), manufactured by Rolence Enteprise, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K040396 · Rolence Enteprise, Inc. · Dental device
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Apr 2004
Decision
65d
Days
Class 2
Risk

K040396 is an FDA 510(k) clearance for the ULTRASONIC SCALER ELEGANCE MS-10 (25K). Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Rolence Enteprise, Inc. (Chungi, TW). The FDA issued a Cleared decision on April 22, 2004 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rolence Enteprise, Inc. devices

FDA 510(k) Submission Details - K040396

510(k) Number K040396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date April 22, 2004
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
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 101
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