uLab Systems Dental Aligner

FDA UDI

Class II (US FDA UDI)

by uLab Systems, Inc

Identity

Trade Name: uLab Systems Dental Aligner FDA UDI
Generic Name: Orthodontic progressive aligner FDA UDI
Model / Reference: FG0094 Rev. D FDA UDI

Identifiers

Primary DI / UDI-DI: 00860002380063 FDA UDI
510(k) Number: K192596 FDA UDI
FDA Product Code: NXC FDA UDI
GMDN Term: Orthodontic progressive aligner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic progressive aligner

uLab Systems Dental Aligner by uLab Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: uLab Systems, Inc

Sources (1)

FDA UDI 5d05c031-2877-47fe-80a7-c748e57bfeae 33 fields · synced May 31, 2026