APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82

FDA 510(k) K033446 · We Dong Myung Dental Industrial Co., Ltd.

Substantially Equivalent

510(k) numberK033446

Submission

Device name
APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82
Applicant
We Dong Myung Dental Industrial Co., Ltd.
Marietta, GA, US
Received
October 29, 2003
Decision date
November 13, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
EJT – Alloy, Gold-Based Noble Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3060
Specialty
Dental

Other 510(k)s with product code EJT

510(k)DeviceApplicantDecision
K052463Prometal HN86EJT · Traditional Prometal Technologies10/14/2005SE
K041378Bio 60EJT · Traditional Kodent, Inc.08/02/2004SE
K040672Porta ReflexEJT · Traditional Wieland Dental + Technik GmbH & Co. KG05/27/2004SE
K040524Porta Solder 1090 WEJT · Traditional Wieland Dental + Technik GmbH & Co. KG05/20/2004SE
K040043NDX-40 AlloyEJT · Traditional Heraeus Kulzer, Inc.03/03/2004SE
K034049Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional Heraeus Kulzer,GmbH03/01/2004SE
K033279Gold Dental Casting AlloysEJT · Traditional Bego U.S.A.01/15/2004SE
K033435E-Sarang 86, DM78, DM55EJT · Traditional We Dong Myung Dental Industrial Co., Ltd.11/12/2003SE
K032320Appollo 3 AlloyEJT · Traditional Dentsply International10/01/2003SE
K032321Cera F AlloyEJT · Traditional Dentsply International09/30/2003SE

More from Dentsply International

510(k)DeviceDecision
K033435E-Sarang 86, DM78, DM55EJT · Traditional 11/12/2003SE
K033434BestaloyEJJ · Traditional 11/12/2003SE
K030206Apex 90EJT · Traditional 01/29/2003SE

Questions and answers

When was APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82 cleared by the FDA?

APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82 (K033446) received a 510(k) decision of Substantially Equivalent on November 13, 2003, 15 days after the submission was received.

What is the product code of K033446?

The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.