Cleared Traditional

K994181 - PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
(FDA 510(k) Clearance)

K994181 · Pulpdent Corp. · Dental

Feb 2000

Decision

81d

Days

Class 2

Risk

K994181 is an FDA 510(k) clearance for the PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH 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 29, 2000, 81 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	K994181 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 1999
Decision Date	February 29, 2000
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement