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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 7005 Appling Farms Parkway, Memphis, TN, 38133
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3017155477
- DUNS Number
- —
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| uLab Systems uDesign | Version 2.2 | FDA UDI | Class II | Unknown |
| uLab Systems uDesign | Version 5.5 | FDA UDI | Class II | Unknown |
| uLab Systems uDesign | 6.0 | FDA UDI | Class II | Active |
| uLab Systems uDesign | 5.9 | FDA UDI | Class II | Unknown |
| uLab Systems uDesign | 10 | FDA UDI | Class II | Active |
| uLab Systems uDesign | 7 | FDA UDI | Class II | Active |
| uLab Systems uDesign | Version 5.8 | FDA UDI | Class II | Active |
| uLab Systems uDesign | 9 | FDA UDI | Class II | Active |
| uLab Systems uDesign | 8 | FDA UDI | Class II | Active |
| uLab Systems Dental Aligner | FG0094 | FDA UDI | Class II | Unknown |
| uLab Systems uDesign | Version 5 | FDA UDI | Class II | Unknown |
| uLab Systems Dental Aligner | FG0094 | FDA UDI | Class II | Active |
| uLab Systems uDesign | Version 5.6 | FDA UDI | Class II | Active |
| Clearjoy Dental Aligner | 1 | FDA UDI | Class II | Unknown |
| uLab Systems Dental Aligner | FG0094 Rev. D | FDA UDI | Class II | Active |
| Reva Thermoforming Sheet Material | FG0010 | FDA UDI | U | Active |
| ULab Systems uDesign Software | K200772 | FDA 510(k) | Class II | Active |
| ULab Systems Treatment Planning Software | K171295 | FDA 510(k) | Class II | Active |
| ULab Systems Dental Aligner Kit | K192596 | FDA 510(k) | Class II | Active |
| uLab Systems Dental Aligner Kit | K211510 | FDA 510(k) | Class II | Active |
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