.022 Comp Clear Six™ Brackets-1 Case Kit

FDA UDI

Class II (US FDA UDI)

by Ortho Specialties

Identity

Trade Name: .022 Comp Clear Six™ Brackets-1 Case Kit FDA UDI
Generic Name: Orthodontic bracket, plastic, single-use FDA UDI
Device Name: 1 Patient Set Of Composite Direct Bond Brackets And Stainless Steel Molar Tubes FDA UDI
Model / Reference: 710-550 FDA UDI
Description: 1 Patient Set Of Composite Direct Bond Brackets And Stainless Steel Molar Tubes FDA UDI

Identifiers

Catalog Number: 710-550 FDA UDI
Primary DI / UDI-DI: 00842452100415 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

Yes

FDA UDI

Category: Orthodontic bracket, plastic, single-use

.022 Comp Clear Six™ Brackets-1 Case Kit by Ortho Specialties — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Ortho Specialties

Sources (1)

FDA UDI d4531a45-6989-4e72-a260-18a4d192ad09 35 fields · synced May 31, 2026