The following data is part of a premarket notification filed by Schuetz Dental Gmbh with the FDA for Capo Bulk Fill.
| Device ID | K152471 |
| 510k Number | K152471 |
| Device Name: | CAPO BULK FILL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SCHUETZ DENTAL GMBH DIESELSTR. 5- 6 Rosbach, DE 61191 |
| Contact | Anke Puent |
| Correspondent | Anke Puent SCHUETZ DENTAL GMBH DIESELSTR. 5- 6 Rosbach, 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 | 2015-08-31 |
| Decision Date | 2016-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBIB750541 | K152471 | 000 |
| EBIB750521 | K152471 | 000 |