The following data is part of a premarket notification filed by Creamed Gmbh & Co. Produktions- Und Handels Kg with the FDA for Ambarino High-class.
| Device ID | K222723 |
| 510k Number | K222723 |
| Device Name: | AMBARINO High-Class |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Creamed GmbH & Co. Produktions- Und Handels KG Tom-Mutters-Str. 4a Marburg, DE 35041 |
| Contact | Robert Lemmer |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-09-08 |
| Decision Date | 2022-09-09 |