Cleared Traditional

INSTRUMENT,FILLING,PLASTIC,DENTAL

K945077 · Worldwide Dental, Inc. · Dental
Nov 1994
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K945077 is an FDA 510(k) clearance for the INSTRUMENT,FILLING,PLASTIC,DENTAL, a Burnisher, Operative (Class I — General Controls, product code EKJ), submitted by Worldwide Dental, Inc. (Clearwater, US). The FDA issued a Cleared decision on November 30, 1994, 44 days after receiving the submission on October 17, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K945077 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 1994
Decision Date November 30, 1994
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EKJ — Burnisher, Operative
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565