Exquisite Restoration Syringe Shade B1 170-B1-Syr

GUDID 00850194007589

Exquisite Restoration Syringe Shade B1

APEX DENTAL MATERIALS INCORPORATED

Light-cured dental restorative composite resin
Primary Device ID00850194007589
NIH Device Record Key2dde3ab2-fd07-42f0-a9c2-54358c7aeffd
Commercial Distribution StatusIn Commercial Distribution
Brand NameExquisite Restoration Syringe Shade B1
Version Model Number1
Catalog Number170-B1-Syr
Company DUNS018651672
Company NameAPEX DENTAL MATERIALS INCORPORATED
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850194007589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-06-16

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