Unismile Clear Aligner

FDA UDI

Class II (US FDA UDI)

by Vitang Technology Llc

Identity

Trade Name: Unismile Clear Aligner FDA UDI
Generic Name: Orthodontic progressive aligner FDA UDI
Model / Reference: Full Package FDA UDI

Identifiers

Primary DI / UDI-DI: 10860012674647 FDA UDI
510(k) Number: K191837 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic progressive aligner

Unismile Clear Aligner by Vitang Technology Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthodontic progressive aligner.

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Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
3M™ Clarity™ — 3M UNITEK CORPORATION · Class II
Risas Reveal Aligners — Ortho Organizers, Inc. · Class II
Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II

Cleared under the same submission

K191837 also covers:

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: Vitang Technology Llc

Sources (1)

FDA UDI 3f84c2b3-331e-4c70-b19f-8428b81e5e63 33 fields · synced May 30, 2026