Eagle-Light, Self & Dual-Cure Core Build-Up Material

FDA UDI

Class II (US FDA UDI)

by Dent Zar, Inc.

Identity

Trade Name: Eagle-Light, Self & Dual-Cure Core Build-Up Material FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: • Eagle-Light, Self & Dual-Cure Core Build-Up Material In dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light. • Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • Moldable, non-sticky consistency. • Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • The Standard Eagle kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics. FDA UDI
Model / Reference: 1009 FDA UDI
Description: • Eagle-Light, Self & Dual-Cure Core Build-Up Material In dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light. • Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • Moldable, non-sticky consistency. • Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • The Standard Eagle kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics. FDA UDI

Identifiers

Catalog Number: 1009 FDA UDI
Primary DI / UDI-DI: D83610091 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

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

Yes

FDA UDI

Category: Dental composite resin

Eagle-Light, Self & Dual-Cure Core Build-Up Material 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 c353d835-1cc2-43a7-a79a-f2d8a591a4ad 34 fields · synced May 31, 2026