ULab Systems uDesign Software
FDA 510(k) clearance K200772 · decided 2020-06-23
Clearance details
- K-number
- K200772
- Device name
- ULab Systems uDesign Software
- Applicant
- Ulab Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-03-25
- Decision date
- 2020-06-23
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PNN
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- San Mateo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.