Cleared Traditional

K860058 - DENPAX

K860058 is an FDA 510(k) clearance for DENPAX, manufactured by Nissho Iwai American Corp.. The device is a Class 1 Dental device with product code EBR cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K860058 · Nissho Iwai American Corp. · Dental device
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Mar 1986
Decision
65d
Days
Class 1
Risk

K860058 is an FDA 510(k) clearance for the DENPAX. Classified as Unit, Suction Operatory (product code EBR), Class I - General Controls.

Submitted by Nissho Iwai American Corp. (New York, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Nissho Iwai American Corp. devices

FDA 510(k) Submission Details - K860058

510(k) Number K860058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date March 12, 1986
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 128d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

EBR Device Classification - Class 1, General Controls

Product Code EBR Unit, Suction Operatory
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.