Cleared Traditional

K994203 - ART-M3 25K

Also marketed or referenced as:
ART-M3 30K, MODEL M3-1-ART3-A1

K994203 is an FDA 510(k) clearance for ART-M3 25K, 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 84-day FDA review.

K994203 · Bonart Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
84d
Days
Class 2
Risk

K994203 is an FDA 510(k) clearance for the ART-M3 25K, MODEL M3-1-ART2-A1. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Bonart Co., Ltd. (Hsingchang, Taipei Hsien, TW). The FDA issued a Cleared decision on March 6, 2000 after a review of 84 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 Bonart Co., Ltd. devices

FDA 510(k) Submission Details - K994203

510(k) Number K994203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1999
Decision Date March 06, 2000
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
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 79
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K994203.
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