FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SIRONA DENTAL CAD/CAM SYSTEM
K Number: K111421
·
Decision Feb 17, 2012
Classifications
1
FEI Numbers
390
Registration Numbers
390
Same Product Code
672
Applicant Total
38
Review Days
273
Basic Information
- Device Name
- SIRONA DENTAL CAD/CAM SYSTEM
- K Number
- K111421
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIRONA DENTAL SYSTEMS GMBH
- Date Received
- May 20, 2011
- Decision Date
- February 17, 2012
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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