Cleared Traditional

DENTAL STOOLS, #'S P2212, P1121, ETC. (K800520) - FDA 510(k) Clearance

K800520 · Vacudent Sales Corp. · Dental device
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Mar 1980
Decision
12d
Days
-
Risk

K800520 is an FDA 510(k) clearance for the DENTAL STOOLS, #'S P2212, P1121, ETC..

Submitted by Vacudent Sales Corp. (Mchenry, US). The FDA issued a Cleared decision on March 18, 1980 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.

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Submission Details

510(k) Number K800520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1980
Decision Date March 18, 1980
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 -