Atlas Dual Cure Cement 1005

GUDID D83610051

Atlas is used for: final cementation of implant prosthesis, crowns, bridges, in-lays, on-lays, Maryland bridges, veneers, cementation of posts and pins, pit and fissure sealants, periodontal splinting, and cementation of orthodontic bands and appliances.. OUTSTANDING FEATURES OF THE MATERIAL •Excellent handling characteristics •Dual-Cured •Fluoride release •X-ray opacity •Low irritation potential •Negligible solubility •Low film thickness •Excellent resistance to oral environment and mechanical strength assure good long-term performance •Long shelf life

DENT ZAR, INC.

Dental composite resin
Primary Device IDD83610051
NIH Device Record Key9961c7d2-e3d0-4e11-9af1-8adfe6dafda4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtlas Dual Cure Cement
Version Model Number1005
Catalog Number1005
Company DUNS789664455
Company NameDENT ZAR, INC.
Device Count5
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
HIBCCD83610050 [Unit of Use]
HIBCCD83610051 [Primary]

FDA Product Code

DYHAdhesive, Bracket And Tooth Conditioner, 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 Date2016-09-03

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