Inspire ICE

FDA UDI

Class II (US FDA UDI)

by Ormco Corporation

Identity

Trade Name: Inspire ICE FDA UDI
Generic Name: Orthodontic bracket, ceramic FDA UDI
Device Name: L1&2 INSPIRE ICE MCLAUGHLIN, BENNETT & TREVISI .022 -6/0/0 FDA UDI
Model / Reference: 444-2011 FDA UDI
Description: L1&2 INSPIRE ICE MCLAUGHLIN, BENNETT & TREVISI .022 -6/0/0 FDA UDI

Identifiers

Primary DI / UDI-DI: 00889989081107 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

Category: Orthodontic bracket, ceramic

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

Similar devices

Also classified as Orthodontic bracket, ceramic.

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Experience — GC Orthodontics America Inc. · Class II
Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
APC™ II Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
EXPERIENCE® — GC Orthodontics America Inc. · Class II
APC™ PLUS Clarity™ SL — 3M UNITEK CORPORATION · 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 db196970-3c85-4eae-94e5-ad8e7ca169a5 35 fields · synced Jun 9, 2026