Cleared Traditional

DECIDENT

K896364 · Nevin Laboratories, Inc. · Dental
Jul 1990
Decision
255d
Days
Class 1
Risk

About This 510(k) Submission

K896364 is an FDA 510(k) clearance for the DECIDENT, a Handpiece, Water-powered (Class I — General Controls, product code EKY), submitted by Nevin Laboratories, Inc. (Chicago, US). The FDA issued a Cleared decision on July 19, 1990, 255 days after receiving the submission on November 6, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K896364 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 1989
Decision Date July 19, 1990
Days to Decision 255 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EKY — Handpiece, Water-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200