Cleared Traditional

PORTA IMPLANT

K030312 · Wieland Dental + Technik GmbH & Co. KG · Dental
Mar 2003
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K030312 is an FDA 510(k) clearance for the PORTA IMPLANT, 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 March 26, 2003, 55 days after receiving the submission on January 30, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K030312 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2003
Decision Date March 26, 2003
Days to Decision 55 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