K173410 is an FDA 510(k) clearance for the n!ce for Planmill. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on November 14, 2017, 13 days after receiving the submission on November 1, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K173410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2017 |
| Decision Date | November 14, 2017 |
| Days to Decision | 13 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |