Cleared Traditional

K022492 - PULPDENT SEMI-GEL ETCH (FDA 510(k) Clearance)

K022492 · Pulpdent Corporation · Dental device

Oct 2002

Decision

74d

Days

Class 2

Risk

K022492 is an FDA 510(k) clearance for the PULPDENT SEMI-GEL ETCH. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on October 11, 2002, 74 days after receiving the submission on July 29, 2002.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K022492 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 29, 2002
Decision Date	October 11, 2002
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF