FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULab Systems uDesign Software
K Number: K200772
·
Decision Jun 23, 2020
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
33
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- ULab Systems uDesign Software
- K Number
- K200772
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ulab Systems, Inc.
- Date Received
- March 25, 2020
- Decision Date
- June 23, 2020
- Product Code
- PNN
- 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 |
|---|---|---|---|
| PNN | Orthodontic Software | FDA class 2 | Dental |
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