Bonding Accessories

FDA UDI

Class II (US FDA UDI)

by Tp Orthodontics, Inc.

Identity

Trade Name: Bonding Accessories FDA UDI
Generic Name: Orthodontic bracket adhesive FDA UDI
Device Name: Enamel Conditioner S FDA UDI
Model / Reference: 150-020 FDA UDI
Description: Enamel Conditioner S FDA UDI

Identifiers

Primary DI / UDI-DI: 00192029000212 FDA UDI
FDA Product Code: DYH FDA UDI
GMDN Term: Orthodontic bracket adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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

Bonding Accessories by Tp Orthodontics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket adhesive.

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Resilience — ORTHO TECHNOLOGY, INC. · Class II
Illuminate — Ortho Organizers, Inc. · Class II
Novocol GRANITEC PRIMER 9ML — Septodont · Class II
Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Light Cure Retainer — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II

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: Tp Orthodontics, Inc.

Sources (1)

FDA UDI 6789b336-4812-4d20-9b49-25c9e0f09ce0 34 fields · synced May 30, 2026