Cleared Traditional

SILICONE SPLINTING MATERIAL (K840113) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K840113 · General Dental Products, Inc. · General & Plastic Surgery device
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Apr 1985
Decision
462d
Days
Class 1
Risk

K840113 is an FDA 510(k) clearance for the SILICONE SPLINTING MATERIAL. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by General Dental Products, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on April 17, 1985 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all General Dental Products, Inc. devices

Submission Details

510(k) Number K840113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1984
Decision Date April 17, 1985
Days to Decision 462 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
347d slower than avg
Panel avg: 115d · This submission: 462d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
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.