The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Calcicur.
| Device ID | K926419 |
| 510k Number | K926419 |
| Device Name: | CALCICUR |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | VOCO GMBH C/O MEDICAL DEVICE RESOURCES 7527 WESTMORELAND AVENUE St. Louis, MO 63105 |
| Contact | Evan G Dick |
| Correspondent | Evan G Dick VOCO GMBH C/O MEDICAL DEVICE RESOURCES 7527 WESTMORELAND AVENUE St. Louis, MO 63105 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-23 |
| Decision Date | 1993-03-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CALCICUR 79097635 4040451 Live/Registered |
VOCO GmbH 2011-02-08 |