Cleared Traditional

K091300 - ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 (FDA 510(k) Clearance)

K091300 · CAO Group, Inc. · Dental device

Jul 2009

Decision

80d

Days

Class 2

Risk

K091300 is an FDA 510(k) clearance for the ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).

Submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on July 23, 2009, 80 days after receiving the submission on May 4, 2009.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K091300 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 04, 2009
Decision Date	July 23, 2009
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF