SpiritMB

FDA UDI

Class II (US FDA UDI)

by Ormco Corporation

Identity

Trade Name: SpiritMB FDA UDI
Generic Name: Orthodontic bracket, plastic, single-use FDA UDI
Device Name: Single Patient Kit - Upper 3x3 - Hooks on Cuspids - L.A. Modern FDA UDI
Model / Reference: 740-1222 FDA UDI
Description: Single Patient Kit - Upper 3x3 - Hooks on Cuspids - L.A. Modern FDA UDI

Identifiers

Primary DI / UDI-DI: 00889989061857 FDA UDI
FDA Product Code: DYW FDA UDI
GMDN Term: Orthodontic bracket, plastic, single-use 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

Yes

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

SpiritMB by Ormco Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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Carriere® Motion Pro™ — Ortho Organizers, Inc. · 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

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: Ormco Corporation

Sources (1)

FDA UDI f7dfdd04-65ab-4a96-9383-a616805a02cf 35 fields · synced Jun 9, 2026