Cleared Traditional

K891338 - SMYLON (DENTAL STAIN ERASER)

K891338 is an FDA 510(k) clearance for SMYLON (DENTAL STAIN ERASER), manufactured by The Smylon Co.. The device is a Class 1 Dental device with product code MAU cleared through the Traditional 510(k) pathway after a 246-day FDA review.

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

FDA 510(k) Submission Details - K891338

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.

MAU Device Classification - Class 1, General Controls

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.