The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Herador Ec, Pf, C, H, Nh, G, Gg And Mp; Heraloy U And G; Herabond N; Albabond C, B And A; Bio Heranorm.
| Device ID | K034049 |
| 510k Number | K034049 |
| Device Name: | HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | HERAEUS KULZER GMBH 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Contact | Cheryl V Zimmerman |
| Correspondent | Cheryl V Zimmerman HERAEUS KULZER GMBH 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-30 |
| Decision Date | 2004-03-01 |