LuxaCore® Smartmix Dual

FDA UDI

Class II (US FDA UDI)

by DMG Chemisch-Pharmazeutische Fabrik GmbH

Identity

Trade Name: LuxaCore® Smartmix Dual FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @ 9 g paste, Accessories. Color: A3 FDA UDI
Model / Reference: 212039 FDA UDI
Description: Core build-up composite. Core buildups and post cementation with 5 stars. Content: 2 syringes @ 9 g paste, Accessories. Color: A3 FDA UDI

Identifiers

Catalog Number: 212039 FDA UDI
Primary DI / UDI-DI: EDMG2120390 FDA UDI
510(k) Number: K012307 FDA UDI
FDA Product Code: EBF FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental composite resin

LuxaCore® Smartmix Dual by DMG Chemisch-Pharmazeutische Fabrik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
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Capo Universal, 6 g — Schütz Dental GmbH · Class II
OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II

Cleared under the same submission

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: DMG Chemisch-Pharmazeutische Fabrik GmbH

Sources (1)

FDA UDI 2b5dd5b7-8157-4c81-8686-934ac40a168c 37 fields · synced Jun 8, 2026