The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Translux Power Blue.
| Device ID | K042199 |
| 510k Number | K042199 |
| Device Name: | TRANSLUX POWER BLUE |
| Classification | Activator, Ultraviolet, For Polymerization |
| 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 | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-13 |
| Decision Date | 2004-09-08 |