The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Cuttersil Activator Universal Plus.
| Device ID | K080338 |
| 510k Number | K080338 |
| Device Name: | CUTTERSIL ACTIVATOR UNIVERSAL PLUS |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-07 |
| Decision Date | 2008-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660374460 | K080338 | 000 |
| J014660374440 | K080338 | 000 |
| J014660374430 | K080338 | 000 |