FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Zenostar MT, Zenostar Color Liquids
K Number: K152118
·
Decision Dec 16, 2015
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
45
Review Days
139
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Basic Information
- Device Name
- Zenostar MT, Zenostar Color Liquids
- K Number
- K152118
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wieland Dental + Technik GmbH & Co. KG
- Date Received
- July 30, 2015
- Decision Date
- December 16, 2015
- Product Code
- EIH
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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Other Clearances by Wieland Dental + Technik GmbH & Co. KG
| K Number | Device Name | ||
|---|---|---|---|
| K151142 | IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID | Aug 13, 2015 | Substantially Equivalent |
| K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr | Jan 5, 2015 | Substantially Equivalent |
| K130184 | ZENOLUX | May 24, 2013 | Substantially Equivalent |
| K112710 | ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR | Oct 17, 2011 | Substantially Equivalent |
| K103773 | ZENOFLEX DIMENSION | Mar 16, 2011 | Substantially Equivalent |
| K103494 | ZENOSTAR MAGIC GLAZE | Feb 16, 2011 | Substantially Equivalent |
| K082257 | ZENO AI ECO DISC | Sep 18, 2008 | Substantially Equivalent |
| K080182 | ZENO PMMA DISC | Apr 8, 2008 | Substantially Equivalent |
| K073108 | ZENO ZR DISC | Nov 21, 2007 | Substantially Equivalent |
| K070772 | PRESSX ZR | Apr 30, 2007 | Substantially Equivalent |