The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for Synergy Flow.
| Device ID | K013400 |
| 510k Number | K013400 |
| Device Name: | SYNERGY FLOW |
| Classification | Material, Tooth Shade, Resin |
| Applicant | COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Contact | H.j. Vogelstein |
| Correspondent | H.j. Vogelstein COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2001-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00671050 | K013400 | 000 |
| J00671040 | K013400 | 000 |
| J00676560 | K013400 | 000 |
| J00676500 | K013400 | 000 |
| J00671160 | K013400 | 000 |
| J00671140 | K013400 | 000 |
| J006600116110 | K013400 | 000 |