Cleared Special

K152064 - Astringedent Clear (FDA 510(k) Clearance)

K152064 · Ultradent Products, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Sep 2015
Decision
62d
Days
-
Risk

K152064 is an FDA 510(k) clearance for the Astringedent Clear. Classified as Cord, Retraction (product code MVL).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 24, 2015 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ultradent Products, Inc. devices

Submission Details

510(k) Number K152064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2015
Decision Date September 24, 2015
Days to Decision 62 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 127d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MVL Cord, Retraction
Device Class -