Cleared Traditional

K994180 - PULPDENT CAVITY PREPARATION III
(FDA 510(k) Clearance)

K994180 · Pulpdent Corp. · Dental

Mar 2000

Decision

83d

Days

Class 2

Risk

K994180 is an FDA 510(k) clearance for the PULPDENT CAVITY PREPARATION III. 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 March 2, 2000, 83 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	K994180 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 1999
Decision Date	March 02, 2000
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement