Acclaim Chemical Cure Composite Restorative Material Single Jar Part B 0052

GUDID D83600520

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.

DENT ZAR, INC.

Dental composite resin
Primary Device IDD83600520
NIH Device Record Keybffd95d1-dcce-4aa9-89bc-085fe5d880f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcclaim Chemical Cure Composite Restorative Material Single Jar Part B
Version Model Number0052
Catalog Number0052
Company DUNS789664455
Company NameDENT ZAR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD83600520 [Primary]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-02

Devices Manufactured by DENT ZAR, INC.

D836TKJGX4 - Polishers2022-03-16 A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishi
D836PSLFH9 - LED Curing Light2022-03-15 A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-bas
D836QXGZK2 - Dental Diamond Burs2022-03-15 Dental burs are a vital tool required for almost every dental treatment and procedure. They are necessary for cutting, grinding,
D83600080 - Acorn Nano Micro Hybrid-Syringe Shade A12018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
D83600090 - Acorn Nano Micro Hybrid-Syringe Shade A22018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
D83600100 - Acorn Nano Micro Hybrid-Syringe Shade A32018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
D83600110 - Acorn Nano Micro Hybrid-Syringe Shade B22018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in
D83600120 - Acorn Nano Micro Hybrid-Syringe Shade A42018-07-06 Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered in

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