FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WDS, SIZE 2 AND SIZE 2
K Number: K061114
·
Decision Jun 6, 2006
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
3
Review Days
46
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Basic Information
- Device Name
- WDS, SIZE 2 AND SIZE 2
- K Number
- K061114
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cefla S.C.R.L.
- Date Received
- April 21, 2006
- Decision Date
- June 6, 2006
- Product Code
- MUH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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