Cleared Traditional

AURO-BRUSH (K781351) - FDA 510(k) Clearance

K781351 · Parker Laboratories, Inc. · Dental device
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Dec 1978
Decision
119d
Days
-
Risk

K781351 is an FDA 510(k) clearance for the AURO-BRUSH.

Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Parker Laboratories, Inc. devices

Submission Details

510(k) Number K781351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1978
Decision Date December 04, 1978
Days to Decision 119 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 127d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -