Cleared Traditional

ASTRON AIR POWERED HIGH SPEED DE PIECE (K801684) - FDA 510(k) Clearance

K801684 · Pacific Dental Corp. · Dental device
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Aug 1980
Decision
14d
Days
-
Risk

K801684 is an FDA 510(k) clearance for the ASTRON AIR POWERED HIGH SPEED DE PIECE.

Submitted by Pacific Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1980 after a review of 14 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 Pacific Dental Corp. devices

Submission Details

510(k) Number K801684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1980
Decision Date August 04, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 127d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -