PMMA CAD/CAM disc

FDA UDI

Class II (US FDA UDI)

by POLIDENT d.o.o.

Identity

Trade Name: PMMA CAD/CAM disc FDA UDI
Generic Name: Temporary dental crown/bridge FDA UDI
Device Name: PMMA CAD/CAM disc A3.5-18-95-Z FDA UDI
Model / Reference: PMMA.709 FDA UDI
Description: PMMA CAD/CAM disc A3.5-18-95-Z FDA UDI

Identifiers

Catalog Number: PMMA.709 FDA UDI
Primary DI / UDI-DI: EPOLPMMA7090 FDA UDI
FDA Product Code: EBG FDA UDI
ELM FDA UDI
GMDN Term: Temporary dental crown/bridge FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 FDA UDI
872.3590 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: Resin artificial teeth Temporary dental crown/bridge

PMMA CAD/CAM disc by POLIDENT d.o.o. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temporary dental crown/bridge.

Visalys Temp — Kettenbach GmbH & Co. KG · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: POLIDENT d.o.o.

Sources (1)

FDA UDI 3e764025-3d22-4380-8b60-0e63d35ec2cf 35 fields · synced Jun 6, 2026