K160262 is an FDA 510(k) clearance for the n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,. 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 September 16, 2016, 227 days after receiving the submission on February 2, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K160262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2016 |
| Decision Date | September 16, 2016 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |