RelyX™ Unicem Aplicap™

FDA UDI

Class I (US FDA UDI)

by 3M Deutschland GmbH

Identity

Trade Name: RelyX™ Unicem Aplicap™ FDA UDI
Generic Name: Dental material injection cannula, single-use FDA UDI
Device Name: 3M™ ESPE™ RelyX™ Unicem Self-Adhesive Universal Resin Cement Aplicap™ Capsule A2 Universal Shade Refill, 56818 FDA UDI
Model / Reference: 56818 FDA UDI
Description: 3M™ ESPE™ RelyX™ Unicem Self-Adhesive Universal Resin Cement Aplicap™ Capsule A2 Universal Shade Refill, 56818 FDA UDI

Identifiers

Catalog Number: 56818 FDA UDI
Primary DI / UDI-DI: J001702011156670 FDA UDI
FDA Product Code: EID FDA UDI
EMA FDA UDI
GMDN Term: Dental material injection cannula, single-use 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

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

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

RelyX™ Unicem Aplicap™ by 3M Deutschland GmbH — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: 3M Deutschland GmbH

Sources (1)

FDA UDI d173a969-2fe0-497d-9b07-356e282b2546 35 fields · synced May 30, 2026