The following data is part of a premarket notification filed by Cendres+metaux Sa with the FDA for Pekkton Ivory.
| Device ID | K170102 |
| 510k Number | K170102 |
| Device Name: | Pekkton Ivory |
| Classification | Material, Tooth Shade, Resin |
| Applicant | CENDRES+METAUX SA Rue De Boujean 122 Biel/bienne, CH 2501 |
| Contact | Uli Diermann |
| Correspondent | Uli Diermann CENDRES+METAUX SA Rue De Boujean 122 Biel/bienne, CH 2501 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-11 |
| Decision Date | 2017-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640166511526 | K170102 | 000 |
| 07640166511502 | K170102 | 000 |
| 07640166511496 | K170102 | 000 |
| 07640166511489 | K170102 | 000 |
| 07640166511472 | K170102 | 000 |
| 07640166511458 | K170102 | 000 |