# Ulab Systems, Inc.

- Location (FDA's records): San Mateo, CA
- FDA decisions: 4 (2018–2022): 4 510(k) clearances
- Product codes: NXC (2), PNN (2)
- 510(k) review time since 2016: median 198 days, against 225 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 8 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smylio, Inc.: 1 (https://510kreport.com/company/smylio)
- 3Shape A/S: 1 (https://510kreport.com/company/3shape-a-s)
- Ortho Caps GmbH: 1 (https://510kreport.com/company/ortho-caps)

## Firms that cite its devices most
- LuxCreo, Inc.: 1 (https://510kreport.com/company/luxcreo)
- 3Shape A/S: 1 (https://510kreport.com/company/3shape-a-s)
- Str8 Oral Care: 1 (https://510kreport.com/company/str8-oral-care)
- Softsmile, Inc.: 1 (https://510kreport.com/company/softsmile)
- Mem Dental Technology Co., Ltd.: 1 (https://510kreport.com/company/mem-dental-technology)
- Key Dental Technologies, LLC: 1 (https://510kreport.com/company/key-dental-technologies)
- Blue Sky Bio, LLC: 1 (https://510kreport.com/company/blue-sky-bio)

## Its most-cited devices
- K192596: ULab Systems Dental Aligner Kit (2020), cited by 4
- K171295: ULab Systems Treatment Planning Software (2018), cited by 3
- K211510: uLab Systems Dental Aligner Kit (2022), cited by 1

## Recent decisions
- K211510: uLab Systems Dental Aligner Kit (Feb 24, 2022)
- K200772: ULab Systems uDesign Software (Jun 23, 2020)
- K192596: ULab Systems Dental Aligner Kit (Feb 11, 2020)
- K171295: ULab Systems Treatment Planning Software (Jan 9, 2018)

Source page: https://510kreport.com/company/ulab-systems