Cleared Traditional

SMYLON (DENTAL STAIN ERASER) (K891338) - FDA 510(k) Clearance

Class I Dental device.

K891338 · The Smylon Co. · Dental device
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Nov 1989
Decision
246d
Days
Class 1
Risk

K891338 is an FDA 510(k) clearance for the SMYLON (DENTAL STAIN ERASER). Classified as Eraser, Dental Stain (product code MAU), Class I - General Controls.

Submitted by The Smylon Co. (Los Angeles, US). The FDA issued a Cleared decision on November 14, 1989 after a review of 246 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - 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 The Smylon Co. devices

Submission Details

510(k) Number K891338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1989
Decision Date November 14, 1989
Days to Decision 246 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 127d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MAU Eraser, Dental Stain
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
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.