FDA.reportPublic FDA data

510(k) K033446

Device
APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82
Applicant
We Dong Myung Dental Industrial Co., Ltd.
510(k) number
K033446
Product code
EJT
Decision
Substantially Equivalent (SESE)
Decision date
2003-11-13
Date received
2003-10-29
Regulation
872.3060
Classification name
Alloy, Gold-Based Noble Metal
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
RONALD D ARKIN
Address
1733 Canton Ln. Marietta GA US 30062 30062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EJT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052463PROMETAL HN86Prometal Technologies2005-10-14
K041378BIO 60Kodent, Inc.2004-08-02
K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KG2004-05-27
K040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KG2004-05-20
K040043NDX-40 ALLOYHeraeus Kulzer, Inc.2004-03-03
K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH2004-03-01
K033279GOLD DENTAL CASTING ALLOYSBego U.S.A.2004-01-15
K033435E-SARANG 86, DM78, DM55We Dong Myung Dental Industrial Co., Ltd.2003-11-12
K032320APPOLLO 3 ALLOYDentsply International2003-10-01
K032321CERA F ALLOYDentsply International2003-09-30
K032319CERA R PLUS ALLOYDentsply International2003-09-30
K032318MINERVA 58 ALLOYDentsply International2003-09-30
K032317ORION GX ALLOYDentsply Intl.2003-09-30
K032316ORION E ALLOYDentsply Intl.2003-09-30
K032715DW 296 #15 SOLDERIvoclar Vivadent, Inc.2003-09-26