Cleared Traditional

K974398 - PULPDENT CAVITY VARNISH
(FDA 510(k) Clearance)

K974398 · Pulpdent Corp. · Dental

Feb 1998

Decision

89d

Days

Class 2

Risk

K974398 is an FDA 510(k) clearance for the PULPDENT CAVITY VARNISH. 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 18, 1998, 89 days after receiving the submission on November 21, 1997.

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

Submission Details

510(k) Number	K974398 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 1997
Decision Date	February 18, 1998
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF