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: Custom-made dental crown, polymer FDA UDI
Device Name: Dental crown/bridge, temporary FDA UDI
Model / Reference: PMMA.198 FDA UDI
Description: Dental crown/bridge, temporary FDA UDI

Identifiers

Catalog Number: PMMA.198 FDA UDI
Primary DI / UDI-DI: EPOLPMMA198 FDA UDI
FDA Product Code: EBG FDA UDI
GMDN Term: Custom-made dental crown, polymer 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Dry Heat Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3 Meter FDA UDI

Category: Partial denture Custom-made dental crown, polymer

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 Custom-made dental crown, polymer.

Ceramill — Vertex-Dental B.V. · Class I
VarseoSmile TriniQ — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG · Class II
Flexcera™ Smile Ultra+ Bleach — Envisiontec GmbH · Class II
VarseoSmile TriniQ — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG · Class II
Vertex-Dental BV — Vertex-Dental B.V. · Class I
Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
VarseoSmile Crown plus — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG · 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 69db634e-3b4f-4e23-a1cd-620591f84cf0 37 fields · synced May 30, 2026