Chic

FDA UDI

Class II (US FDA UDI)

by GC Orthodontics America Inc.

Identity

Trade Name: Chic FDA UDI
Generic Name: Orthodontic bracket, ceramic FDA UDI
Device Name: CHIC ROTH 022/L5 -22T 0A 0D FDA UDI
Model / Reference: 14-2650-0010 FDA UDI
Description: CHIC ROTH 022/L5 -22T 0A 0D FDA UDI

Identifiers

Catalog Number: 14-2650-0010 FDA UDI
Primary DI / UDI-DI: E53514265000101 FDA UDI
FDA Product Code: NJM FDA UDI
GMDN Term: Orthodontic bracket, ceramic 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthodontic bracket, ceramic

Chic by GC Orthodontics America 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: GC Orthodontics America Inc.

Sources (1)

FDA UDI d7230187-694a-47fa-8c4d-9a3cbd3424bd 35 fields · synced May 30, 2026