K170102 is an FDA 510(k) clearance for the Pekkton Ivory. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Cendres & Metaux SA (Biel/Bienne, CH). The FDA issued a Cleared decision on November 13, 2017, 306 days after receiving the submission on January 11, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K170102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2017 |
| Decision Date | November 13, 2017 |
| Days to Decision | 306 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF - Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |