EU College Kit

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name: EU College Kit FDA UDI
Generic Name: Orthodontic bracket adhesive FDA UDI
Device Name: The University College Kit includes 1 syringe Ultra Band Lok Blue NonFluoride, 1 syringe GoTo bracket adhesive, 1 x 2ml bottle Assure Plus Universal Bonding Resin, 1 x Flowtain syringe for lingual retention, Ortho FlexTech and Retainium Lingual retainer wires and Technical Bonding Cards FDA UDI
Model / Reference: EUUNIVHAND FDA UDI
Description: The University College Kit includes 1 syringe Ultra Band Lok Blue NonFluoride, 1 syringe GoTo bracket adhesive, 1 x 2ml bottle Assure Plus Universal Bonding Resin, 1 x Flowtain syringe for lingual retention, Ortho FlexTech and Retainium Lingual retainer wires and Technical Bonding Cards FDA UDI

Identifiers

Catalog Number: EUUNIVHAND FDA UDI
Primary DI / UDI-DI: D798EUUNIVHAND0 FDA UDI
FDA Product Code: KLE FDA UDI
DYH FDA UDI
DZC FDA UDI
EBF FDA UDI
GMDN Term: Orthodontic bracket adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3200 FDA UDI
872.3750 FDA UDI
872.5410 FDA UDI
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

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

Category: Dentine bonding agent/set Orthodontic wire Orthodontic bracket adhesive

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

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ALPHA-DENT® Paste & Paste Orthodontic Adhesive — Dental Technologies, Inc.

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 95a229d7-241d-4a2a-a94e-82c94aeb5ce0 36 fields · synced Jun 6, 2026