FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ZENO PMMA DISC
K Number: K080182
·
Decision Apr 8, 2008
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
45
Review Days
74
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Basic Information
- Device Name
- ZENO PMMA DISC
- K Number
- K080182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wieland Dental + Technik GmbH & Co. KG
- Date Received
- January 25, 2008
- Decision Date
- April 8, 2008
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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