RE-GEN Bulk Fill Composite and Resin Cement A2 Refill 90658

GUDID 00850194007503

RE-GEN Bulk Fill Composite and Resin Cement A2 Refill

APEX DENTAL MATERIALS INCORPORATED

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID00850194007503
NIH Device Record Key43f99f0a-8c72-4302-b0e0-d2e1baf8bddb
Commercial Distribution StatusIn Commercial Distribution
Brand NameRE-GEN Bulk Fill Composite and Resin Cement A2 Refill
Version Model Number1
Catalog Number90658
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
GS100850194007503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin
KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-16
Device Publish Date2016-06-16

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00850194007848 - VistaCORE 25ml Cartridge Kit Shade A22019-12-23 VistaCORE 25ml Cartridge Kit Shade A2
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