Cleared Traditional

AURO-BRUSH

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

About This 510(k) Submission

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, 119 days after receiving the submission on August 7, 1978. This device falls under the Dental review panel.

Submission Details

510(k) Number K781351 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 1978
Decision Date December 04, 1978
Days to Decision 119 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code
Device Class