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Pink CAD/CAM Disc

FDA UDI

Class II (US FDA UDI)

by POLIDENT d.o.o.

Identity

Trade Name
Pink CAD/CAM Disc FDA UDI
Generic Name
Partial denture FDA UDI
Device Name
Denture base resin heat-cured FDA UDI
Model / Reference
PMMP.489 FDA UDI
Description
Denture base resin heat-cured FDA UDI

Identifiers

Catalog Number
PMMP.489 FDA UDI
Primary DI / UDI-DI
EPOLPMMP489 FDA UDI
510(k) Number
K153546 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Partial denture FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Dry Heat Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 3 Meter FDA UDI

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

Cleared under the same submission

K153546 also covers:

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 4ff923a1-a538-4a4a-ae11-1dc0dddedf86 39 fields · synced May 30, 2026