Cleared Traditional

K854168 - TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES (FDA 510(k) Clearance)

Class I Dental device.

K854168 · Travenol Laboratories, S.A. · Dental device
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Mar 1986
Decision
149d
Days
Class 1
Risk

K854168 is an FDA 510(k) clearance for the TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES. Classified as Instrument, Hand, Calculus Removal (product code ELA), Class I - General Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on March 13, 1986 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K854168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date March 13, 1986
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ELA Instrument, Hand, Calculus Removal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.