Lucitone® HIPA

FDA UDI

Class II (US FDA UDI)

by Dentsply International

Identity

Trade Name: Lucitone® HIPA FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: Original Opaque. Contains 100g powder, 100ml liquid FDA UDI
Model / Reference: Trial Kit (5 Units) FDA UDI
Description: Original Opaque. Contains 100g powder, 100ml liquid FDA UDI

Identifiers

Catalog Number: 905900 FDA UDI
Primary DI / UDI-DI: D0019059000 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 100 Milliliter FDA UDI
Weight — 100 Gram FDA UDI

Category: Dental appliance fabrication material, resin

Lucitone® HIPA by Dentsply International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Dentsply International

Sources (1)

FDA UDI 7e05afe3-3354-415b-aafa-398c49351ce5 36 fields · synced May 30, 2026