The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Ionolux Pro.
| Device ID | K102450 |
| 510k Number | K102450 |
| Device Name: | IONOLUX PRO |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STR 1-3 Cuxhaven, DE D-27472 |
| Contact | Manfred T Plaumann |
| Correspondent | Manfred T Plaumann VOCO GMBH ANTON-FLETTNER-STR 1-3 Cuxhaven, DE D-27472 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-27 |
| Decision Date | 2010-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22121241 | K102450 | 000 |
| E22119911 | K102450 | 000 |
| E22119921 | K102450 | 000 |
| E22121151 | K102450 | 000 |
| E22121171 | K102450 | 000 |
| E22121181 | K102450 | 000 |
| E22121191 | K102450 | 000 |
| E22121201 | K102450 | 000 |
| E22121211 | K102450 | 000 |
| E22121221 | K102450 | 000 |
| E22121231 | K102450 | 000 |
| E22119901 | K102450 | 000 |