Zircules™ A3 5mL

FDA UDI

Class II (US FDA UDI)

by Den-Mat Holdings, LLC

Identity

Trade Name: Zircules™ A3 5mL FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Zirconia Nano-Filled Core Material FDA UDI
Model / Reference: 406503 FDA UDI
Description: Zirconia Nano-Filled Core Material FDA UDI

Identifiers

Catalog Number: 406503 FDA UDI
Primary DI / UDI-DI: 00359883005290 FDA UDI
FDA Product Code: EBF FDA UDI
EID FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
872.4565 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

FDA UDI

Dimensions & Sizes

Size: Total Volume — 5 Milliliter FDA UDI

Category: Dental composite resin

Zircules™ A3 5mL by Den-Mat Holdings, LLC — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Den-Mat Holdings, LLC

Sources (1)

FDA UDI 56bfd095-fe3d-4534-817c-5a91b2bdbba7 37 fields · synced Jun 9, 2026