Lumineers®

FDA UDI

Class I (US FDA UDI)

by Den-Mat Holdings, LLC

Identity

Trade Name: Lumineers® FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: LUMINEERS STARTER KIT IT FDA UDI
Model / Reference: LUM1005-99 FDA UDI
Description: LUMINEERS STARTER KIT IT FDA UDI

Identifiers

Catalog Number: LUM1005-99 FDA UDI
Primary DI / UDI-DI: D813LUM1005990 FDA UDI
FDA Product Code: DZP FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4535 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental composite resin

Lumineers® by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
Llis — Dentscare Ltda · Class II
Capo Universal, 6 g — Schütz Dental GmbH · Class II
OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Den-Mat Holdings, LLC

Sources (1)

FDA UDI 0610bff0-f594-4323-99bc-8a0feb08feee 35 fields · synced Jun 9, 2026