Phase II

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name: Phase II FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. This is a chemical cure adhesive system. The highly-filled paste provides a strong mechanical bond with metal and ceramic bracket bases. This Kit contains 18g Adhesive Paste A with fluoride in a Jar, 18g Adhesive Paste B in a Jars, 7g Maximum Cure Filled Bonding Resin A with Fluoride & Maximum Cure Filled Bonding Resin B, 9g liquid Etchant , mixing pad, spatulas and disposable brushes This Kit contains Fluoride. This kit contains Maximum Cure Sealants in place of Bonding Resin. FDA UDI
Model / Reference: PJMCFF FDA UDI
Description: Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. This is a chemical cure adhesive system. The highly-filled paste provides a strong mechanical bond with metal and ceramic bracket bases. This Kit contains 18g Adhesive Paste A with fluoride in a Jar, 18g Adhesive Paste B in a Jars, 7g Maximum Cure Filled Bonding Resin A with Fluoride & Maximum Cure Filled Bonding Resin B, 9g liquid Etchant , mixing pad, spatulas and disposable brushes This Kit contains Fluoride. This kit contains Maximum Cure Sealants in place of Bonding Resin. FDA UDI

Identifiers

Catalog Number: PJMCFF FDA UDI
Primary DI / UDI-DI: D798PJMCFF0 FDA UDI
510(k) Number: K894566 FDA UDI
K895523 FDA UDI
FDA Product Code: DYH FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3750 FDA UDI
Commercial Distribution: Not 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Phase II by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K894566 also covers:

K895523 also covers:

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 5c837534-060e-4e32-bc92-b0e48fa96b21 38 fields · synced Jun 1, 2026