Cleared Traditional

RANIR PLAX RX

K935906 · Ranir/Dcp Corp. · Dental
Sep 1994
Decision
266d
Days
Class 1
Risk

About This 510(k) Submission

K935906 is an FDA 510(k) clearance for the RANIR PLAX RX, a Mirror, Mouth (Class I — General Controls, product code EAX), submitted by Ranir/Dcp Corp. (Grand Rapids, US). The FDA issued a Cleared decision on September 2, 1994, 266 days after receiving the submission on December 10, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K935906 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1993
Decision Date September 02, 1994
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EAX — Mirror, Mouth
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565