Cleared Traditional

DIXON SCISSORS, STARINLESS STEEL, OPERATING TYPE (K844667) - FDA 510(k) Clearance

K844667 · William Dixon Co. · Dental device
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Dec 1984
Decision
12d
Days
-
Risk

K844667 is an FDA 510(k) clearance for the DIXON SCISSORS, STARINLESS STEEL, OPERATING TYPE.

Submitted by William Dixon Co. (Carlstadt, US). The FDA issued a Cleared decision on December 12, 1984 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. 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 William Dixon Co. devices

Submission Details

510(k) Number K844667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date December 12, 1984
Days to Decision 12 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 127d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -