Cleared Traditional

ORX DENT-AIDE DENTAL EMERGENCY KIT (K820501) - FDA 510(k) Clearance

K820501 · Dental Aide Products · Dental device
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Apr 1982
Decision
53d
Days
-
Risk

K820501 is an FDA 510(k) clearance for the ORX DENT-AIDE DENTAL EMERGENCY KIT.

Submitted by Dental Aide Products (Mchenry, US). The FDA issued a Cleared decision on April 19, 1982 after a review of 53 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.

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Submission Details

510(k) Number K820501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1982
Decision Date April 19, 1982
Days to Decision 53 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 127d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -