FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
K Number: K122065
·
Decision Feb 8, 2013
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
4
Applicant Total
40
Review Days
210
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Basic Information
- Device Name
- DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
- K Number
- K122065
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3661
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ormco Corp.
- Date Received
- July 13, 2012
- Decision Date
- February 8, 2013
- Product Code
- NOF
- 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 |
|---|---|---|---|
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | FDA class 2 | Dental |
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| K062856 | TF ROTARY NICKEL TITANIUM FILE | Dec 13, 2006 | Substantially Equivalent |
| K061481 | GRENGLOO | Jul 6, 2006 | Substantially Equivalent |