FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TF ROTARY NICKEL TITANIUM FILE
K Number: K062856
·
Decision Dec 13, 2006
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
30
Applicant Total
40
Review Days
79
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Basic Information
- Device Name
- TF ROTARY NICKEL TITANIUM FILE
- K Number
- K062856
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ormco Corp.
- Date Received
- September 25, 2006
- Decision Date
- December 13, 2006
- Product Code
- EKS
- 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 |
|---|---|---|---|
| EKS | File, Pulp Canal, Endodontic | FDA class 1 | Dental |
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