RelyX™ Unicem 2 Automix

FDA UDI

Class II (US FDA UDI)

by 3M Deutschland GmbH

Identity

Trade Name: RelyX™ Unicem 2 Automix FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: 3M™ ESPE™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement Translucent Shade Value Pack, 56858 DM DI = 04035077018913 FDA UDI
Model / Reference: 56858 FDA UDI
Description: 3M™ ESPE™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement Translucent Shade Value Pack, 56858 DM DI = 04035077018913 FDA UDI

Identifiers

Catalog Number: 56858 FDA UDI
Primary DI / UDI-DI: 04035077007016 FDA UDI
FDA Product Code: EMA FDA UDI
EID FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3275 FDA UDI
872.4565 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

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: Dental composite resin Dental material injection cannula, single-use Dental material mixing nozzle

RelyX™ Unicem 2 Automix by 3M Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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BL-42A — Zhaoqing Gaoyao Recende Medical Equipment Co.,LTD · Class I
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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 88bc0bd8-6eb2-4afd-bdd3-8d0a54e4bfc3 35 fields · synced May 29, 2026