The following data is part of a premarket notification filed by Schutz Dental Gmbh with the FDA for Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow.
| Device ID | K151399 |
| 510k Number | K151399 |
| Device Name: | Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SCHUTZ DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, DE De 61191 |
| Contact | Antje Maurer |
| Correspondent | Antje Maurer SCHUTZ DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, DE De 61191 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-26 |
| Decision Date | 2016-10-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBIB750791 | K151399 | 000 |
| EBIB740611 | K151399 | 000 |
| EBIB740621 | K151399 | 000 |
| EBIB740701 | K151399 | 000 |
| EBIB750701 | K151399 | 000 |
| EBIB750711 | K151399 | 000 |
| EBIB750721 | K151399 | 000 |
| EBIB750751 | K151399 | 000 |
| EBIB750761 | K151399 | 000 |
| EBIB750771 | K151399 | 000 |
| EBIB750781 | K151399 | 000 |
| EBIB740601 | K151399 | 000 |