Cleared Traditional

K896821 - OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE (FDA 510(k) Clearance)

Class I Dental device.

K896821 · North American Sterilization & Packaging Co. · Dental device
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Feb 1990
Decision
67d
Days
Class 1
Risk

K896821 is an FDA 510(k) clearance for the OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE. Classified as Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) (product code KOQ), Class I - General Controls.

Submitted by North American Sterilization & Packaging Co. (Sparta, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 67 days - a notably fast clearance cycle.

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: 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 North American Sterilization & Packaging Co. devices

Submission Details

510(k) Number K896821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date February 09, 1990
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 127d · This submission: 67d
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.