FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TIO-H DIGITAL RADIOGRAPHY SENSOR
K Number: K153144
·
Decision Feb 10, 2016
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
201
Applicant Total
1
Review Days
103
Basic Information
- Device Name
- TIO-H DIGITAL RADIOGRAPHY SENSOR
- K Number
- K153144
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DENTTIO, INC.
- Date Received
- October 30, 2015
- Decision Date
- February 10, 2016
- 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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