Luxatemp® Ultra

FDA UDI

Class II (US FDA UDI)

by DMG Chemisch-Pharmazeutische Fabrik GmbH

Identity

Trade Name: Luxatemp® Ultra FDA UDI
Generic Name: Temporary dental crown/bridge FDA UDI
Device Name: Temporary crown and bridge material automix system; bis acrylic composite. For a look that is hard to beat. Content: 1 syringe @ 15 g paste, accessories. Color: BL. FDA UDI
Model / Reference: 110905 FDA UDI
Description: Temporary crown and bridge material automix system; bis acrylic composite. For a look that is hard to beat. Content: 1 syringe @ 15 g paste, accessories. Color: BL. FDA UDI

Identifiers

Catalog Number: 110905 FDA UDI
Primary DI / UDI-DI: EDMG1109050 FDA UDI
510(k) Number: K101710 FDA UDI
FDA Product Code: EBG FDA UDI
GMDN Term: Temporary dental crown/bridge FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 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: Temporary dental crown/bridge

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

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IDODENTINE — UNION DENTAL SA · Class II
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Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
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Cleared under the same submission

K101710 also covers:

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 4c92caad-db84-4ea9-a67e-2c84a8e3671e 37 fields · synced May 30, 2026