Cleared Traditional

K854168 - TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES

K854168 is an FDA 510(k) clearance for TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES, manufactured by Travenol Laboratories, S.A.. The device is a Class 1 Dental device with product code ELA cleared through the Traditional 510(k) pathway after a 149-day FDA review.

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

FDA 510(k) Submission Details - K854168

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

ELA Device Classification - Class 1, General Controls

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.