FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA
K Number: K113431
·
Decision Mar 30, 2012
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
471
Applicant Total
1
Review Days
130
Basic Information
- Device Name
- CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA
- K Number
- K113431
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BETTINI S.P.A.
- Date Received
- November 21, 2011
- Decision Date
- March 30, 2012
- 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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