FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
DentiqGuide
K Number: K180629
·
Decision Jul 19, 2018
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
4
Review Days
132
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Basic Information
- Device Name
- DentiqGuide
- K Number
- K180629
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3D Industrial Imaging Co., Ltd.
- Date Received
- March 9, 2018
- Decision Date
- July 19, 2018
- Product Code
- LLZ
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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