ULab Systems Dental Aligner Kit
ULab Systems, Inc.
uLab Systems, Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017155477 | 3017155477 | uLab Systems, Inc | 1 | N | 2026-01-01 | 7005 Appling Farms Parkway Memphis TN US 38133 |
| 3014273880 | 3014273880 | ULab Systems, Inc. | 1 | N | 2020-04-25 | 1820 Gateway Drive Suite 300 San Mateo CA US 94404 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 274297 | 2010113536 | K211510 | uLab Systems Dental Aligner Kit | NXC | 2022-02-24 |
| 274297 | 1989172654 | K200772 | ULab Systems uDesign Software | PNN | 2020-06-23 |
| 274297 | 1347743823 | K192596 | ULab Systems Dental Aligner Kit | NXC | 2020-02-11 |
| 215580 | 1253153032 | K171295 | ULab Systems Treatment Planning Software | PNN | 2018-01-09 |
| 274297 | 1253153032 | K171295 | ULab Systems Treatment Planning Software | PNN | 2018-01-09 |
| 274297 | 1668725199 |
Product Codes Associated With Registrations#
PMN#
ULab Systems UDesign Software
ULab Systems, Inc.
ULab Systems Dental Aligner Kit
ULab Systems, Inc.
ULab Systems Treatment Planning Software
ULab Systems, Inc.
GUDID#
Reva Thermoforming Sheet Material - The uLab Systems Reva Disc is a non-sterile sheet of thermoplastic intended to be used by a dental practitioner to fabricate polymer orthodontic and dental appliances. The sheets of material are heated by the dental practitioner in an office setting and then vacuum-formed over a dental impression of the patient’s teeth. Once formed, the appliance is then trimmed to fit the patient.
2025-04-29
Clearjoy Dental Aligner - The Clearjoy Dental Aligner kit is a line extension of the uLab Systems Dental Aligner Kit and is an orthodontic treatment system, that consists of doctor-prescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient’s teeth gradually to the ideal position.
2023-11-02
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
2025-01-28
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
2024-05-20
uLab Systems Dental Aligner - The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctor-prescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient’s teeth gradually to the ideal position.
2022-06-01
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
2023-11-02
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
2021-05-10
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
2022-04-11
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
2020-11-16
uLab Systems Dental Aligner - FG0094 Rev. D
2020-10-12
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
2020-07-14
uLab Systems Dental Aligner - FG0094
2020-07-20
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
2020-07-10
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers
2019-09-18
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers
2020-02-18
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers
2018-08-20
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers
2020-02-18
uLab Systems uDesign - The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers
2019-09-18