Cleared Traditional

K994182 - PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
(FDA 510(k) Clearance)

K994182 · Pulpdent Corp. · Dental

Feb 2000

Decision

75d

Days

Class 2

Risk

K994182 is an FDA 510(k) clearance for the PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE. This device is classified as a Varnish, Cavity (Class II — Special Controls, product code LBH).

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on February 23, 2000, 75 days after receiving the submission on December 10, 1999.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number	K994182 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 1999
Decision Date	February 23, 2000
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement