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Phase II

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name
Phase II FDA UDI
Generic Name
Orthodontic bracket adhesive FDA UDI
Device Name
PhaseII® Dual Cure is intended for use as an orthodontic adhesive for direct and indirect bonding. This kit contains 3 X 6g Phase II Pastes A with Fluoride & B in screw syringes, 2 X 3cc Light Bond Sealant Resins and 1x 9g liquid etchant with and mixing accessories. Kit contains fluoride. FDA UDI
Model / Reference
DCSF FDA UDI
Description
PhaseII® Dual Cure is intended for use as an orthodontic adhesive for direct and indirect bonding. This kit contains 3 X 6g Phase II Pastes A with Fluoride & B in screw syringes, 2 X 3cc Light Bond Sealant Resins and 1x 9g liquid etchant with and mixing accessories. Kit contains fluoride. FDA UDI

Identifiers

Catalog Number
DCSF FDA UDI
Primary DI / UDI-DI
D798DCSF0 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Reliance Orthodontic Products, Inc.

Sources (1)

  • FDA UDI 0a8f2e44-546e-4cd1-b048-ed72a4b4eae5 37 fields · synced Jun 7, 2026