Carriere

FDA UDI

Class II (US FDA UDI)

by Ortho Organizers, Inc.

Identity

Trade Name: Carriere FDA UDI
Generic Name: Orthodontic bracket, plastic, single-use FDA UDI
Device Name: Carriere® MOTION 3D CLEAR™ Class II 23mm FDA UDI
Model / Reference: 424-823LC FDA UDI
Description: Carriere® MOTION 3D CLEAR™ Class II 23mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00190707005719 FDA UDI
510(k) Number: K160720 FDA UDI
FDA Product Code: DYW FDA UDI
EJF FDA UDI
GMDN Term: Orthodontic bracket, plastic, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5470 FDA UDI
872.5410 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

Category: Orthodontic bracket, plastic, single-use

Carriere by Ortho Organizers, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket, plastic, single-use.

ZENITH™ ROTH COMPOSITE BRACKETS (KIT) — G&H Wire Company, Inc. · Class II
LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
Silkon Plus — American Orthodontics · Class II
LUCENT™ MBT METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
Silkon Plus — American Orthodontics · Class II
PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II
LUCENT™ EDGEWISE METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc. · Class II

Cleared under the same submission

K160720 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: Ortho Organizers, Inc.

Sources (1)

FDA UDI 3303ecbc-d303-4037-8728-d65b4f1261b9 34 fields · synced Jun 9, 2026