Cleared Traditional

PULPDENT PUTTY DAM

K022522 · Pulpdent Corporation · Dental
Sep 2002
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K022522 is an FDA 510(k) clearance for the PULPDENT PUTTY DAM, a Dam, Rubber (Class I — General Controls, product code EIE), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on September 26, 2002, 58 days after receiving the submission on July 30, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number K022522 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2002
Decision Date September 26, 2002
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIE — Dam, Rubber
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6300