Cleared Traditional

K954820 - SCALEX 800

K954820 is an FDA 510(k) clearance for SCALEX 800, manufactured by Dentamerica. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K954820 · Dentamerica · Dental device
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Jan 1996
Decision
90d
Days
Class 2
Risk

K954820 is an FDA 510(k) clearance for the SCALEX 800. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dentamerica (Industry, US). The FDA issued a Cleared decision on January 18, 1996 after a review of 90 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 Dentamerica devices

FDA 510(k) Submission Details - K954820

510(k) Number K954820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1995
Decision Date January 18, 1996
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 84
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