Cleared Traditional

K081550 - BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO

K081550 is an FDA 510(k) clearance for BONART ULTRASONIC SCALER, manufactured by Bonart Co., Ltd.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K081550 · Bonart Co., Ltd. · Dental device
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Aug 2008
Decision
86d
Days
Class 2
Risk

K081550 is an FDA 510(k) clearance for the BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Bonart Co., Ltd. (Walnut, US). The FDA issued a Cleared decision on August 28, 2008 after a review of 86 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.

FDA 510(k) Submission Details - K081550

510(k) Number K081550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2008
Decision Date August 28, 2008
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 128d · This submission: 86d
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 155
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