Cleared Traditional

K901882 - URESIL ENDOSCOPIC LASER OVERTUBE

K901882 is an FDA 510(k) clearance for URESIL ENDOSCOPIC LASER OVERTUBE, manufactured by Uresil Corp.. The device is a Class 1 Dental device with product code KOQ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K901882

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

KOQ Device Classification - Class 1, General Controls

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.