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: Resin artificial teeth FDA UDI
Device Name: PMMA CAD/CAM disc B4-16-95-Z MULTILAYER FDA UDI
Model / Reference: PMMAML.343 FDA UDI
Description: PMMA CAD/CAM disc B4-16-95-Z MULTILAYER FDA UDI

Identifiers

Catalog Number: PMMAML.343 FDA UDI
Primary DI / UDI-DI: EPOLPMMAML3430 FDA UDI
FDA Product Code: EBG FDA UDI
ELM FDA UDI
GMDN Term: Resin artificial teeth 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

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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: POLIDENT d.o.o.

Sources (1)

FDA UDI 99fc7d0d-9e05-4b13-b2c0-60e9fa3ed030 35 fields · synced Jun 1, 2026