Cleared Traditional

K952867 - REMANIUM:GM 700, GM 380, GM 800, GFH
(FDA 510(k) Clearance)

K952867 · Dentauraum, Inc. · Dental
Jul 1995
Decision
35d
Days
Class 2
Risk

K952867 is an FDA 510(k) clearance for the REMANIUM:GM 700, GM 380, GM 800, GFH, 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 27, 1995, 35 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 K952867 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1995
Decision Date July 27, 1995
Days to Decision 35 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