The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Aqua Ionofil.
| Device ID | K922853 |
| 510k Number | K922853 |
| Device Name: | AQUA IONOFIL |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-15 |
| Decision Date | 1992-08-10 |