Cleared Traditional

K830106 - UNICIDE

K830106 is an FDA 510(k) clearance for UNICIDE, manufactured by North Pacific Dental, Inc.. The device is a Class 2 Dental device with product code LFE cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K830106 · North Pacific Dental, Inc. · Dental device
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Mar 1983
Decision
55d
Days
Class 2
Risk

K830106 is an FDA 510(k) clearance for the UNICIDE. Classified as Solution, Cold Sterilizing (product code LFE), Class II - Special Controls.

Submitted by North Pacific Dental, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1983 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 880.6885 - 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 Pacific Dental, Inc. devices

FDA 510(k) Submission Details - K830106

510(k) Number K830106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date March 07, 1983
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 128d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFE Device Classification - Class 2, Special Controls

Product Code LFE Solution, Cold Sterilizing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.