Tooth Shade Resin Material

FDA UDI

Class II (US FDA UDI)

by Liaoning Upcera Co., Ltd.

Identity

Trade Name: Tooth Shade Resin Material FDA UDI
Generic Name: Dentine bonding agent/set FDA UDI
Model / Reference: SHT-S-W2-D(98-14) FDA UDI

Identifiers

Primary DI / UDI-DI: 06942201742447 FDA UDI
FDA Product Code: EBF FDA UDI
GMDN Term: Dentine bonding agent/set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

FDA UDI

HCT/P

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Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

Yes

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Category: Dentine bonding agent/set

For dentists and dental professionals, the Tooth Shade Resin Material is a high-quality bonding agent used to attach composite restorations or fillings. It's designed for use in permanent teeth, with a controlled setting that allows for precise placement and minimal damage to surrounding tissue.

Similar devices

Also classified as Dentine bonding agent/set.

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G-Premio™ BOND — Gc America Inc. · Class II
Name: Ena Bond Seal Model: Light curing Sealer bonding agent Resin — Micerium S.p.A. · Class IIa
Scotchbond™ Universal — 3M Deutschland GmbH · Class II
Monobond Etch Prime — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
Scotchbond™ Universal — 3M Deutschland GmbH · 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: Liaoning Upcera Co., Ltd.

Sources (1)

FDA UDI 2bf557e4-eefd-46e8-9610-35fff9ff0445 32 fields · synced Jul 24, 2026