3M™ Ketac™ Molar Aplicap™

FDA UDI

Class II (US FDA UDI)

by 3M Deutschland GmbH

Identity

Trade Name: 3M™ Ketac™ Molar Aplicap™ FDA UDI
Generic Name: Glass ionomer dental cement FDA UDI
Device Name: 3M™ Ketac™ Molar Aplicap™ Glass Ionomer Restorative Material, 56433, A3 Shade FDA UDI
Model / Reference: 56433 FDA UDI
Description: 3M™ Ketac™ Molar Aplicap™ Glass Ionomer Restorative Material, 56433, A3 Shade FDA UDI

Identifiers

Primary DI / UDI-DI: 04064035106591 FDA UDI
FDA Product Code: EMA FDA UDI
GMDN Term: Glass ionomer dental cement FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Yes

FDA UDI

Category: Glass ionomer dental cement

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

Similar devices

Also classified as Glass ionomer dental cement.

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SciPharm Until Temporary Crown and Bridge Cement — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
Precedent — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Vivid Glass Restorative A2 Std Pkg — PEARSON DENTAL SUPPLIES, INC. · Class II
GC Fuji II LC® — Gc America Inc. · Class II
GC Fuji LINING™ — Gc America Inc. · Class II
Prontolute Glass Ionomer Luting Cement 30g — ADVANCED HEALTHCARE LTD. · Class IIa

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 cae8c04d-1121-42c4-b8d9-09fb9afc97e2 34 fields · synced Jun 1, 2026