FDA.reportPublic FDA data

510(k) K003603

Device
BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE
Applicant
Jelenko Co.
510(k) number
K003603
Product code
EJT
Decision
Substantially Equivalent (SESE)
Decision date
2001-01-10
Date received
2000-11-21
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
Statement
Third party reviewed
N

Applicant Contact#

Contact
RAPHAEL JUDKINS
Address
99 Business Park Dr. Armonk NY US 10504 10504

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K033446APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82We Dong Myung Dental Industrial Co., Ltd.2003-11-13
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