Cleared Traditional

AGC SPECIAL ALLOY

K023392 · Wieland Dental + Technik GmbH & Co. KG · Dental
Dec 2002
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K023392 is an FDA 510(k) clearance for the AGC SPECIAL ALLOY, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on December 6, 2002, 58 days after receiving the submission on October 9, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K023392 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2002
Decision Date December 06, 2002
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

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