Cleared Traditional

K830115 - PAPER POINTS

K830115 is an FDA 510(k) clearance for PAPER POINTS, manufactured by North Pacific Dental, Inc.. The device is a Class 1 Dental device with product code EKM cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K830115 · North Pacific Dental, Inc. · Dental device
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Mar 1983
Decision
49d
Days
Class 1
Risk

K830115 is an FDA 510(k) clearance for the PAPER POINTS. Classified as Gutta-percha (product code EKM), Class I - General Controls.

Submitted by North Pacific Dental, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1983 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3850 - 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 - K830115

510(k) Number K830115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date March 01, 1983
Days to Decision 49 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 128d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

EKM Device Classification - Class 1, General Controls

Product Code EKM Gutta-percha
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3850
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.