Eagle-Dual-Cured Core Build-Up Material in Auto-Mix Cartridges

FDA UDI

Class II (US FDA UDI)

by Dent Zar, Inc.

Identity

Trade Name: Eagle-Dual-Cured Core Build-Up Material in Auto-Mix Cartridges FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Eagle-Dual-Cure Core Build-Up Material Auto-Mix System • Convenient working time in self-cure mode. • Light-cure properties of the material facilitate cure of the product. • Well balanced x-ray opacity permits tooth structure, pins, and posts to be easily distinguishable from material. • Does not require refrigeration; long shelf-life at ambient temperatures. • Significantly saves chair-time due to its auto-mix system. • Intra-oral tips permit application of the material directly into the tooth. FDA UDI
Model / Reference: 1020 FDA UDI
Description: Eagle-Dual-Cure Core Build-Up Material Auto-Mix System • Convenient working time in self-cure mode. • Light-cure properties of the material facilitate cure of the product. • Well balanced x-ray opacity permits tooth structure, pins, and posts to be easily distinguishable from material. • Does not require refrigeration; long shelf-life at ambient temperatures. • Significantly saves chair-time due to its auto-mix system. • Intra-oral tips permit application of the material directly into the tooth. FDA UDI

Identifiers

Catalog Number: 1020 FDA UDI
Primary DI / UDI-DI: D83610201 FDA UDI
FDA Product Code: EBF FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 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

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

Category: Dental composite resin

Eagle-Dual-Cured Core Build-Up Material in Auto-Mix Cartridges by Dent Zar, Inc. — 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: Dent Zar, Inc.

Sources (1)

FDA UDI 0d5b9c36-5f3a-45cd-9b6a-71a68791ef5f 34 fields · synced May 30, 2026