Phase II

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name: Phase II FDA UDI
Generic Name: Dentine bonding agent/set FDA UDI
Device Name: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. The highly-filled paste provides a strong mechanical bond with metal and ceramic bracket bases. Kit contains: 18g Catalyst Paste A with fluoride, 18g Base Paste B, 7g Bonding Resin A with fluoride &B, 9g Liquid Etchant, mixing pad, spatulas, disposable brushes. This is a Fluoride kit with Screw Syringe Dispensing. FDA UDI
Model / Reference: PSF FDA UDI
Description: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. The highly-filled paste provides a strong mechanical bond with metal and ceramic bracket bases. Kit contains: 18g Catalyst Paste A with fluoride, 18g Base Paste B, 7g Bonding Resin A with fluoride &B, 9g Liquid Etchant, mixing pad, spatulas, disposable brushes. This is a Fluoride kit with Screw Syringe Dispensing. FDA UDI

Identifiers

Catalog Number: PSF FDA UDI
Primary DI / UDI-DI: D798PSF0 FDA UDI
FDA Product Code: DYH FDA UDI
KLE FDA UDI
GMDN Term: Dentine bonding agent/set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3750 FDA UDI
872.3200 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dentine bonding agent/set Dental etching solution Orthodontic bracket adhesive

Phase II 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 77400d6b-2c32-45f8-97c1-85849646689b 36 fields · synced May 30, 2026