Cleared Abbreviated

Ascent 3D

K150585 · CAO Group, Inc. · Dental
Dec 2015
Decision
297d
Days
Class 2
Risk

About This 510(k) Submission

K150585 is an FDA 510(k) clearance for the Ascent 3D, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on December 31, 2015, 297 days after receiving the submission on March 9, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K150585 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2015
Decision Date December 31, 2015
Days to Decision 297 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBZ — Activator, Ultraviolet, For Polymerization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6070

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