RelyX™ Unicem 2 Automix

FDA UDI

Class I (US FDA UDI)

by 3M Deutschland GmbH

Identity

Trade Name: RelyX™ Unicem 2 Automix FDA UDI
Generic Name: Dental material mixing nozzle FDA UDI
Device Name: 3M™ ESPE™ RelyX™ Unicem 2 Automix Self Adhesive Resin Cement Shade A2 Refill, 56846 FDA UDI
Model / Reference: 56846 FDA UDI
Description: 3M™ ESPE™ RelyX™ Unicem 2 Automix Self Adhesive Resin Cement Shade A2 Refill, 56846 FDA UDI

Identifiers

Catalog Number: 56846 FDA UDI
Primary DI / UDI-DI: 04035077007054 FDA UDI
FDA Product Code: EID FDA UDI
EMA FDA UDI
GMDN Term: Dental material mixing nozzle FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
872.3275 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 I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental material mixing nozzle.

Adhesive Tip Applicator — Huanghua Promisee Dental Co.Ltd. · Class I
3.2 Mixing Tips with Integrated Needle 25-Pack — Den-Mat Holdings, LLC · Class I
BENCO — BENCO DENTAL SUPPLY CO. · Class I
Cling2®/Temptation® Now 1:1 Mixing Tips — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
#1031-EU — Kuraray Noritake Dental Inc. Kurashiki · Class I
Plasdent — PLASDENT CORP. · Class I
BL-42A — Zhaoqing Gaoyao Recende Medical Equipment Co.,LTD · Class I
Britedent — BRIGHT SUPPLY INC · Class I

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 I	Pending data

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Manufacturer

Manufacturer: 3M Deutschland GmbH

Sources (1)

FDA UDI b28c0935-c0b4-4721-8bc3-0190464365c5 35 fields · synced May 30, 2026