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EJT — Alloy, Gold-Based Noble Metal Class II

FDA Device Classification

FDA product code EJT covers "Alloy, Gold-Based Noble Metal", a Class II medical device regulated under 21 CFR 872.3060. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EJT
Device Class
Class II
Regulation Number
872.3060
Submission Type
510(k) Exempt
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K052463Prometal TechnologiesPROMETAL HN86Oct 14, 2005
K041378KodentBIO 60Aug 2, 2004
K040672Wieland Dental + Technik Gmbh And Co. KgPORTA REFLEXMay 27, 2004
K040524Wieland Dental + Technik Gmbh And Co. KgPORTA SOLDER 1090 WMay 20, 2004
K040043Heraeus KulzerNDX-40 ALLOYMar 3, 2004
K034049Heraeus KulzerHERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C…Mar 1, 2004
K033279Bego UGOLD DENTAL CASTING ALLOYSJan 15, 2004
K033446We Dong Myung Dental Industrial CoAPEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82Nov 13, 2003
K033435We Dong Myung Dental Industrial CoE-SARANG 86, DM78, DM55Nov 12, 2003
K032320Dentsply InternationalAPPOLLO 3 ALLOYOct 1, 2003
K032316Dentsply IntlORION E ALLOYSep 30, 2003
K032321Dentsply InternationalCERA F ALLOYSep 30, 2003
K032318Dentsply InternationalMINERVA 58 ALLOYSep 30, 2003
K032317Dentsply IntlORION GX ALLOYSep 30, 2003
K032319Dentsply InternationalCERA R PLUS ALLOYSep 30, 2003
K032851Dentsply InternationalULTRACROWN 75 ALLOYSep 26, 2003
K032715Ivoclar VivadentDW 296 #15 SOLDERSep 26, 2003
K032267Jensen IndustriesR&D DESIGNATION AP-052-5Sep 17, 2003
K032493Ivoclar VivadentALEXANDERSep 4, 2003
K032106Star Refining Precious Metals South AfricaSTARBOND DENTAL BONDING ALLOYSAug 25, 2003

FDA data resources