The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Ionoseal.
| Device ID | K912495 |
| 510k Number | K912495 |
| Device Name: | IONOSEAL |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | VOCO GMBH C/ONDA RESOURCES 790 WASHINGTON STREET, STE 301 Denver, CO 80203 |
| Contact | Gail E Gillenwater |
| Correspondent | Gail E Gillenwater VOCO GMBH C/ONDA RESOURCES 790 WASHINGTON STREET, STE 301 Denver, CO 80203 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-05 |
| Decision Date | 1991-07-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IONOSEAL 79228758 not registered Dead/Abandoned |
VOCO GmbH 2018-01-11 |