The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Ionofil/lonofil Molar.
| Device ID | K915619 |
| 510k Number | K915619 |
| Device Name: | IONOFIL/LONOFIL MOLAR |
| Classification | Cement, Dental |
| Applicant | VOCO GMBH C/ONDA RESOURCES 790 WASHINGTON STREET, STE 301 Denver, CO 80203 |
| Contact | Gail Gillenwater |
| Correspondent | Gail 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 | 1991-12-16 |
| Decision Date | 1992-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22116341 | K915619 | 000 |
| E22116321 | K915619 | 000 |
| E22116311 | K915619 | 000 |