Cleared Traditional

K093620 - PULPDENT FLUORIDE VARNISH
(FDA 510(k) Clearance)

K093620 · Pulpdent Corporation · Dental

Mar 2010

Decision

107d

Days

Class 2

Risk

K093620 is an FDA 510(k) clearance for the PULPDENT FLUORIDE VARNISH, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on March 10, 2010, 107 days after receiving the submission on November 23, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number	K093620 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 23, 2009
Decision Date	March 10, 2010
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF