FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EDLENi Intra-Oral Sensor
K Number: K150823
·
Decision Aug 26, 2015
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
3
Review Days
152
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Basic Information
- Device Name
- EDLENi Intra-Oral Sensor
- K Number
- K150823
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edlen Imaging, LLC
- Date Received
- March 27, 2015
- Decision Date
- August 26, 2015
- 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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