FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOPIX INSIDE, SOPIX2 INSIDE
K Number: K140013
·
Decision Sep 5, 2014
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
4
Review Days
246
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Basic Information
- Device Name
- SOPIX INSIDE, SOPIX2 INSIDE
- K Number
- K140013
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sopro - Acteon Group
- Date Received
- January 2, 2014
- Decision Date
- September 5, 2014
- 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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Other Clearances by Sopro - Acteon Group
| K Number | Device Name | ||
|---|---|---|---|
| K153367 | S698 Symbioz flow | Jun 17, 2016 | Substantially Equivalent |
| K142995 | SOPIX | Aug 17, 2015 | Substantially Equivalent |
| K151053 | PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner | Jul 31, 2015 | Substantially Equivalent |