The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Structur 2.
| Device ID | K941124 |
| 510k Number | K941124 |
| Device Name: | STRUCTUR 2 |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | VOCO GMBH C/O MEDICAL DEVICE RESOURCES 7527 WESTMORELAND AVENUE St. Louis, MO 63105 |
| Contact | Evan G Dick, Ph.d |
| Correspondent | Evan G Dick, Ph.d VOCO GMBH C/O MEDICAL DEVICE RESOURCES 7527 WESTMORELAND AVENUE St. Louis, MO 63105 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-09 |
| Decision Date | 1994-04-13 |