The following data is part of a premarket notification filed by Bredent Gmbh & Co.kg with the FDA for Biohpp - Brecam.biohpp.
| Device ID | K152113 |
| 510k Number | K152113 |
| Device Name: | BioHPP - BreCAM.BioHPP |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Bredent GmbH & Co.KG Weissenhorner Strasse 2 Senden, DE 89250 |
| Contact | Stefanie Bochtler |
| Correspondent | Stefanie Bochtler Bredent GmbH & Co.KG Weissenhorner Strasse 2 Senden, DE 89250 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-29 |
| Decision Date | 2016-07-21 |
| Summary: | summary |