Cleared Traditional

K901882 - URESIL ENDOSCOPIC LASER OVERTUBE (FDA 510(k) Clearance)

Class I Dental device.

K901882 · Uresil Corp. · Dental device
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Jul 1990
Decision
92d
Days
Class 1
Risk

K901882 is an FDA 510(k) clearance for the URESIL ENDOSCOPIC LASER OVERTUBE. Classified as Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) (product code KOQ), Class I - General Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on July 27, 1990 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3410 - 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 Uresil Corp. devices

Submission Details

510(k) Number K901882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1990
Decision Date July 27, 1990
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOQ Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3410
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.