Cleared Traditional

K853882 - SUPER SLICK

K853882 is an FDA 510(k) clearance for SUPER SLICK, manufactured by Tang Products. The device is a Class 1 Dental device with product code KMT cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K853882 · Tang Products · Dental device
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Nov 1985
Decision
60d
Days
Class 1
Risk

K853882 is an FDA 510(k) clearance for the SUPER SLICK. Classified as Tray, Fluoride, Disposable (product code KMT), Class I - General Controls.

Submitted by Tang Products (Aurora, US). The FDA issued a Cleared decision on November 18, 1985 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6870 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tang Products devices

FDA 510(k) Submission Details - K853882

510(k) Number K853882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1985
Decision Date November 18, 1985
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 128d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

KMT Device Classification - Class 1, General Controls

Product Code KMT Tray, Fluoride, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6870
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.