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Medental

FDA UDI

Class II (US FDA UDI)

by Medental International Inc

Identity

Trade Name
Medental FDA UDI
Generic Name
Zinc polycarboxylate dental cement FDA UDI
Device Name
P.C.A. Cement kit 25gr. 15ml. FDA UDI
Model / Reference
PCCS25g15ml FDA UDI
Description
P.C.A. Cement kit 25gr. 15ml. FDA UDI

Identifiers

Catalog Number
0PT452 FDA UDI
Primary DI / UDI-DI
P07502291840028 FDA UDI
510(k) Number
K980990 FDA UDI
FDA Product Code
EMA FDA UDI
GMDN Term
Zinc polycarboxylate dental cement FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3275 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Zinc polycarboxylate dental cement

Medental by Medental International Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Zinc polycarboxylate dental cement.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medental International Inc

Sources (1)

  • FDA UDI cf4c9f2c-8ef9-477b-a677-e16aff98c47f 35 fields · synced Jun 8, 2026