Cleared Traditional

PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT

K012427 · Specialites Septodont · Dental

Oct 2001

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K012427 is an FDA 510(k) clearance for the PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT, a Tester, Pulp (Class II — Special Controls, product code EAT), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on October 9, 2001, 70 days after receiving the submission on July 31, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.1720.

Submission Details

510(k) Number	K012427 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2001
Decision Date	October 09, 2001
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement