Cleared Special

K063703 - CITRIC ACID 20% SOLUTION, MODEL 329 (FDA 510(k) Clearance)

K063703 · Ultradent Products, Inc. · Dental device
Dec 2006
Decision
8d
Days
—
Risk

K063703 is an FDA 510(k) clearance for the CITRIC ACID 20% SOLUTION, MODEL 329. This device is classified as a Cleanser, Root Canal.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 21, 2006, 8 days after receiving the submission on December 13, 2006.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K063703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2006
Decision Date December 21, 2006
Days to Decision 8 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KJJ — Cleanser, Root Canal
Device Class —