Exquisite Restoration Syringe Shade A4 170-A4-Syr

GUDID 00850194007572

Exquisite Restoration Syringe Shade A4

APEX DENTAL MATERIALS INCORPORATED

Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin Light-cured dental restorative composite resin
Primary Device ID00850194007572
NIH Device Record Key3fc67ea2-6e62-4fd7-b760-b3840705df10
Commercial Distribution StatusIn Commercial Distribution
Brand NameExquisite Restoration Syringe Shade A4
Version Model Number1
Catalog Number170-A4-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
GS100850194007572 [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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