Lucitone Digital Fuse™

FDA UDI

Class II (US FDA UDI)

by Dentsply International

Identity

Trade Name: Lucitone Digital Fuse™ FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Model / Reference: Step 2 - 3D Denture Bonding Agent - Light Reddish Pink FDA UDI

Identifiers

Catalog Number: 906189 FDA UDI
Primary DI / UDI-DI: D0019061890 FDA UDI
FDA Product Code: EBD FDA UDI
KLE FDA UDI
EBI FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3310 FDA UDI
872.3200 FDA UDI
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

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

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 25 Gram FDA UDI

Category: Dental appliance fabrication material, resin

Lucitone Digital Fuse™ 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 8c096716-b87d-4329-bf63-9184e780b80f 35 fields · synced May 31, 2026