Cleared Traditional

K833039 - HANDY IIM

K833039 is the FDA 510(k) clearance for HANDY IIM by Shofu Dental Corp.. It is a Class 1 Dental device (product code EJP) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K833039 · Shofu Dental Corp. · Dental device
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Oct 1983
Decision
28d
Days
Class 1
Risk

K833039 is an FDA 510(k) clearance for the HANDY IIM. Classified as Articulators (product code EJP), Class I - General Controls.

Submitted by Shofu Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3150 - 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 Shofu Dental Corp. devices

Submission Details

510(k) Number K833039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1983
Decision Date October 04, 1983
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJP Articulators
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3150
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.