Cleared Special

K152064 - Astringedent Clear

K152064 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K152064

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 128d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 35
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K152064.
Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials
K162948 · Kerr Corporation · Aug 2017
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
K162536 · Kerr Corporation · Feb 2017
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
K162164 · Kerr Corporation · Jan 2017
EXPAZEN
K150423 · Produits Dentaires Pierre Rolland (Acteon Group) · Jul 2015
RETRACTION PASTE
K130580 · Dmg USA, Inc. · Feb 2014
QUICKNIT
K131799 · Microcopy, Div. of Neo-Flo, Inc. · Jan 2014
K152064 · Astringedent Clear
Download PDF FDA Summary Ultradent Products, I…