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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 A2-35-100-AG FDA UDI
Model / Reference
PMMA.795 FDA UDI
Description
PMMA CAD/CAM disc A2-35-100-AG FDA UDI

Identifiers

Catalog Number
PMMA.795 FDA UDI
Primary DI / UDI-DI
EPOLPMMA7950 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Resin artificial teethTemporary 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
POLIDENT d.o.o.

Sources (1)

  • FDA UDI 8cd21622-fcc4-4590-a99c-4ac657f61340 35 fields · synced May 30, 2026