Acclaim Chemical Cure Composite Restorative Material Single Jar Part A

FDA UDI

Class II (US FDA UDI)

by Dent Zar, Inc.

Identity

Trade Name: Acclaim Chemical Cure Composite Restorative Material Single Jar Part A FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Acclaim is a highly polishable, self cure, paste/paste, Bis-GMA composite for anterior and posterior restorations. Material exhibits; high mechanical strength and excellent marginal adaptation. High filler content contributes to low shrinkage, low water sorption, low coefficient of thermal expansion and good wear and scratch resistance. Acclaim has a very good x-ray opacity, outstanding color stability and resistance to staining. FDA UDI
Model / Reference: 0051 FDA UDI
Description: Acclaim is a highly polishable, self cure, paste/paste, Bis-GMA composite for anterior and posterior restorations. Material exhibits; high mechanical strength and excellent marginal adaptation. High filler content contributes to low shrinkage, low water sorption, low coefficient of thermal expansion and good wear and scratch resistance. Acclaim has a very good x-ray opacity, outstanding color stability and resistance to staining. FDA UDI

Identifiers

Catalog Number: 0051 FDA UDI
Primary DI / UDI-DI: D83600510 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

Acclaim Chemical Cure Composite Restorative Material Single Jar Part A by Dent Zar, Inc. — Class II — FDA UDI — listed in FDA GUDID

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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 3d9d60e2-adf8-433f-b3c6-1e40dd924fb2 34 fields · synced Jun 7, 2026