Cleared Traditional

V-GNATHOS PLUS

K952122 · Metalor Dental USA Corp. · Dental
Jun 1995
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K952122 is an FDA 510(k) clearance for the V-GNATHOS PLUS, 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 June 6, 1995, 32 days after receiving the submission on May 5, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K952122 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1995
Decision Date June 06, 1995
Days to Decision 32 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