Cleared Traditional

K052028 - BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)

K052028 is an FDA 510(k) clearance for BONART ART-M3II & M4 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 93-day FDA review.

K052028 · Bonart Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
93d
Days
Class 2
Risk

K052028 is an FDA 510(k) clearance for the BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS). 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 October 28, 2005 after a review of 93 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.

FDA 510(k) Submission Details - K052028

510(k) Number K052028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2005
Decision Date October 28, 2005
Days to Decision 93 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
35d faster than avg
Panel avg: 128d · This submission: 93d
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
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K052028.
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