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Idodentine

FDA UDI

Class II (US FDA UDI)

by Union Dental Sa

Identity

Trade Name
IDODENTINE FDA UDI
Generic Name
Temporary dental crown/bridge FDA UDI
Device Name
IDODENTINE DISC PINK VEINED 95/30mm FDA UDI
Model / Reference
DISC PINK V 95/30mm FDA UDI
Description
IDODENTINE DISC PINK VEINED 95/30mm FDA UDI

Identifiers

Catalog Number
4230Z/PV FDA UDI
Primary DI / UDI-DI
08435288442044 FDA UDI
510(k) Number
K150432 FDA UDI
FDA Product Code
EBI FDA UDI
EBG FDA UDI
GMDN Term
Temporary dental crown/bridge FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 FDA UDI
872.3770 FDA UDI
Commercial Distribution
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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Temporary dental crown/bridge

Idodentine by Union Dental Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temporary dental crown/bridge.

Cleared under the same submission

K150432 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Union Dental Sa

Sources (1)

  • FDA UDI 714ffafe-2925-4fa6-9449-49a7e4fbb52c 35 fields · synced Jun 1, 2026