Cleared Traditional

IMPLANTALOY

K954702 · Metalor Dental USA Corp. · Dental
Oct 1995
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K954702 is an FDA 510(k) clearance for the IMPLANTALOY, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on October 30, 1995, 18 days after receiving the submission on October 12, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K954702 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 1995
Decision Date October 30, 1995
Days to Decision 18 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJT — Alloy, Gold-based Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060

Similar Devices — EJT Alloy, Gold-based Noble Metal

All 626
PROMETAL HN86
K052463 · Prometal Technologies · Oct 2005
BIO 60
K041378 · Kodent, Inc. · Aug 2004
PORTA REFLEX
K040672 · Wieland Dental + Technik GmbH & Co. KG · May 2004
PORTA SOLDER 1090 W
K040524 · Wieland Dental + Technik GmbH & Co. KG · May 2004
NDX-40 ALLOY
K040043 · Heraeus Kulzer, Inc. · Mar 2004
HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM
K034049 · Heraeus Kulzer,GmbH · Mar 2004