Submission Details
| 510(k) Number | K152118 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 30, 2015 |
| Decision Date | December 16, 2015 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
Zenostar MT, Zenostar Color Liquids
Dec 2015
Decision
139d
Days
Class 2
Risk
About This 510(k) Submission
K152118 is an FDA 510(k) clearance for the Zenostar MT, Zenostar Color Liquids, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Wieland Dental + Technik GmbH & Co. KG (Pfozheim, DE). The FDA issued a Cleared decision on December 16, 2015, 139 days after receiving the submission on July 30, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.
Device Classification
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.6660 |
Manufacturer
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