3m™

FDA UDI

Class II (US FDA UDI)

by 3M Deutschland GmbH

Identity

Trade Name: 3M™ FDA UDI
Generic Name: Dentine bonding agent/set FDA UDI
Device Name: 3M™ ESPE™ RelyX™ Fiber Post 3D Post and Core Kit/Unicem 2, 56960. Sterilization prior to use only for RelyX Fiber Post Drills. Do not sterilize either RelyX Unicem 2 Automix nor RelyX Fiber Posts. FDA UDI
Model / Reference: 56960 FDA UDI
Description: 3M™ ESPE™ RelyX™ Fiber Post 3D Post and Core Kit/Unicem 2, 56960. Sterilization prior to use only for RelyX Fiber Post Drills. Do not sterilize either RelyX Unicem 2 Automix nor RelyX Fiber Posts. FDA UDI

Identifiers

Catalog Number: 56960 FDA UDI
Primary DI / UDI-DI: J001702011443030 FDA UDI
FDA Product Code: EBF FDA UDI
ELR FDA UDI
EMA FDA UDI
KLE FDA UDI
DZA FDA UDI
EID FDA UDI
GMDN Term: Dentine bonding agent/set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
872.3810 FDA UDI
872.3275 FDA UDI
872.3200 FDA UDI
872.4130 FDA UDI
872.4565 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

Yes

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental composite resin Dentine bonding agent/set Dental material injection cannula, single-use Root canal post, preformed

3m™ by 3M Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: 3M Deutschland GmbH

Sources (1)

FDA UDI ddd3d670-7f59-4bde-b953-beeaa01a3ae3 36 fields · synced May 30, 2026