Cleared Traditional

LIGHT CURE DENTAL DAM

K021524 · Prime Dental Manufacturing, Inc. · Dental
Jul 2002
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K021524 is an FDA 510(k) clearance for the LIGHT CURE DENTAL DAM, a Dam, Rubber (Class I — General Controls, product code EIE), submitted by Prime Dental Manufacturing, Inc. (Chicago, US). The FDA issued a Cleared decision on July 19, 2002, 70 days after receiving the submission on May 10, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number K021524 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2002
Decision Date July 19, 2002
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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