Cleared Traditional

K240801 - BioSonic US200 Ultrasonic Scaler (60034537) (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240801 · Dent4you AG · Dental device
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Jul 2024
Decision
98d
Days
Class 2
Risk

K240801 is an FDA 510(k) clearance for the BioSonic US200 Ultrasonic Scaler (60034537). Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dent4you AG (Heerbrugg, CH). The FDA issued a Cleared decision on July 1, 2024 after a review of 98 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.

View all Dent4you AG devices

Submission Details

510(k) Number K240801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2024
Decision Date July 01, 2024
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 194
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