Cleared Traditional

K032627 - ULTRADENT CITRIC ACID 10% SOLUTION (FDA 510(k) Clearance)

K032627 · Ultradent Products, Inc. · Dental device

Nov 2003

Decision

78d

Days

—

Risk

K032627 is an FDA 510(k) clearance for the ULTRADENT CITRIC ACID 10% SOLUTION. This device is classified as a Cleanser, Root Canal.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 12, 2003, 78 days after receiving the submission on August 26, 2003.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K032627 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 26, 2003
Decision Date	November 12, 2003
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement

Device Classification

Product Code	KJJ — Cleanser, Root Canal
Device Class	—