Phase II Dual Cure

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name: Phase II Dual Cure FDA UDI
Generic Name: Orthodontic bracket adhesive FDA UDI
Device Name: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. This is Dual Cure. 1 X 6g Dual Cure Phase II Adhesive Paste A with Fluoride in screw syringe FDA UDI
Model / Reference: 1DCSAF FDA UDI
Description: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. This is Dual Cure. 1 X 6g Dual Cure Phase II Adhesive Paste A with Fluoride in screw syringe FDA UDI

Identifiers

Catalog Number: 1DCSAF FDA UDI
Primary DI / UDI-DI: D7981DCSAF0 FDA UDI
FDA Product Code: EBF FDA UDI
GMDN Term: Orthodontic bracket adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic bracket adhesive

Phase II Dual Cure by Reliance Orthodontic Products, 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: Reliance Orthodontic Products, Inc.

Sources (1)

FDA UDI 1b60b664-306b-48ca-8850-a85dcfa944c8 36 fields · synced May 30, 2026