DD tempMED

FDA UDI

Class II (US FDA UDI)

by Dental Direkt GmbH

Identity

Trade Name: DD tempMED FDA UDI
Generic Name: Temporary dental crown/bridge FDA UDI
Device Name: DD tempMED are pre-colored dental milling blanks out of PMMA for the manufacture of temporary crowns and bridges for long-term application in the oral cavity up to 12 months. FDA UDI
Model / Reference: 98H20 A1 FDA UDI
Description: DD tempMED are pre-colored dental milling blanks out of PMMA for the manufacture of temporary crowns and bridges for long-term application in the oral cavity up to 12 months. FDA UDI

Identifiers

Catalog Number: K11620 FDA UDI
Primary DI / UDI-DI: EDDIK116201 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

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

Dimensions & Sizes

Size: Height — 20 Millimeter FDA UDI
Outer Diameter — 98.5 Millimeter FDA UDI

Category: Temporary dental crown/bridge

DD tempMED by Dental Direkt GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temporary dental crown/bridge.

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artBloc Temp — Merz Dental GmbH · Class II
VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
IDODENTINE — UNION DENTAL SA · Class II
10TEMP — UNION DENTAL SA · Class II
Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II

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: Dental Direkt GmbH

Sources (1)

FDA UDI e3666c8e-3630-4083-b158-ff162d0b1536 36 fields · synced Jun 8, 2026