ULAB SYSTEMS, INC.

Address:7005 Appling Farms Parkway,Memphis,TN,38133,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthodontic Software (PNN) (7) System, Image Processing, Radiological (LLZ) (7) Aligner, Sequential (NXC) (3)

Premarket Exempt

No Yes

Clear

uLab Systems uDesign - 00860002380001 Catalog Number : FG0064

Device Description : The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw

Device Class : 2

Duns Number: 081092722

Premarket Exempt : Yes

Product Code : LLZ, PNN

Prescription Use : No

Device Count : 1

uLab Systems uDesign - 00860002380018 Catalog Number : FG0064

Device Description : The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw

Device Class : 2

Duns Number: 081092722

Premarket Exempt : Yes

Product Code : LLZ, PNN

Prescription Use : No

Device Count : 1

uLab Systems uDesign - 00860002380025 Catalog Number : FG0064

Device Description : The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw

Device Class : 2

Duns Number: 081092722

Premarket Exempt : Yes

Product Code : LLZ, PNN

Prescription Use : No

Device Count : 1

uLab Systems uDesign - 00860002380032 Catalog Number : FG0064

Device Description : The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw

Device Class : 2

Duns Number: 081092722

Premarket Exempt : Yes

Product Code : LLZ, PNN

Prescription Use : Yes

Device Count : 1

uLab Systems uDesign - 00860002380049 Catalog Number : FG0064

Device Description : The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw

Device Class : 2

Duns Number: 081092722

Premarket Exempt : No

Product Code : LLZ, PNN

Prescription Use : Yes

Device Count : 1

uLab Systems Dental Aligner - 00860002380056 Catalog Number :

Device Class : 2

Duns Number: 081092722

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

uLab Systems Dental Aligner - 00860002380063 Catalog Number :

Device Class : 2

Duns Number: 081092722

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

uLab Systems uDesign - 00860002380070 Catalog Number :

Device Description : The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw

Device Class : 2

Duns Number: 081092722

Premarket Exempt : No

Product Code : LLZ, PNN

Prescription Use : Yes

Device Count : 1

uLab Systems uDesign - 00860002380087 Catalog Number :

Device Description : The uLab Systems uDesign is orthodontic diagnosis and treatment simulation softw

Device Class : 2

Duns Number: 081092722

Premarket Exempt : No

Product Code : LLZ, PNN

Prescription Use : Yes

Device Count : 1

uLab Systems Dental Aligner - 00860002380094 Catalog Number :

Device Description : The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that con

Device Class : 2

Duns Number: 081092722

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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