Cleared Traditional

K942139 - SUPRASSON P MAX

K942139 is an FDA 510(k) clearance for SUPRASSON P MAX, manufactured by Satelec. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 514-day FDA review.

K942139 · Satelec · Dental device
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Sep 1995
Decision
514d
Days
Class 2
Risk

K942139 is an FDA 510(k) clearance for the SUPRASSON P MAX. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Satelec (Merignac, FR). The FDA issued a Cleared decision on September 29, 1995 after a review of 514 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Satelec devices

FDA 510(k) Submission Details - K942139

510(k) Number K942139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1994
Decision Date September 29, 1995
Days to Decision 514 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
387d slower than avg
Panel avg: 127d · This submission: 514d
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 74
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