The following data is part of a premarket notification filed by Den-mat Holdings, Llc with the FDA for Nuance Flow.
| Device ID | K143679 |
| 510k Number | K143679 |
| Device Name: | Nuance FLOW |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Den-Mat Holdings, LLC 1017 W. Central Ave Sata Maria, CA 93436 |
| Contact | Helen Ragus |
| Correspondent | Helen Ragus Den-Mat Holdings, LLC 1017 W. Central Ave Sata Maria, CA 93436 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813CR12170 | K143679 | 000 |
| D813CR12150 | K143679 | 000 |
| D813CR12140 | K143679 | 000 |
| D813CR12130 | K143679 | 000 |
| D813CR12120 | K143679 | 000 |
| D813CR12100 | K143679 | 000 |
| D813CR12090 | K143679 | 000 |