Cleared Traditional

REMANIUM: 200,CS, 380, AND CD

K952865 · Dentauraum, Inc. · Dental
Jul 1995
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K952865 is an FDA 510(k) clearance for the REMANIUM: 200,CS, 380, AND CD, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on July 26, 1995, 34 days after receiving the submission on June 22, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number K952865 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1995
Decision Date July 26, 1995
Days to Decision 34 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJH — Alloy, Metal, Base
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3710