VistaCORE 25ml Cartridge Shade White Opaque

GUDID 00850194007824

VistaCORE 25ml Cartridge Shade White Opaque

APEX DENTAL MATERIALS INCORPORATED

Dental composite resin
Primary Device ID00850194007824
NIH Device Record Keyc23b0738-54b3-4c3b-8ff6-74aadf283d5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameVistaCORE 25ml Cartridge Shade White Opaque
Version Model Number1
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
GS100850194007824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-23
Device Publish Date2019-12-13

Devices Manufactured by APEX DENTAL MATERIALS INCORPORATED

00850194007787 - Purify+ Gel 5 Pack2019-12-23 Purify+ Gel 5 Pack
00850194007794 - Purify+ Liquid 5 Pack2019-12-23 Purify+ Liquid 5 Pack
00850194007800 - VistaCORE 5ml Syringe Shade A22019-12-23 VistaCORE 5ml Syringe Shade A2
00850194007817 - VistaCORE 5ml Syringe Shade White Opaque2019-12-23 VistaCORE 5ml Syringe Shade White Opaque
00850194007824 - VistaCORE 25ml Cartridge Shade White Opaque2019-12-23VistaCORE 25ml Cartridge Shade White Opaque
00850194007824 - VistaCORE 25ml Cartridge Shade White Opaque2019-12-23 VistaCORE 25ml Cartridge Shade White Opaque
00850194007831 - VistaCORE 25ml Cartridge Shade A22019-12-23 VistaCORE 25ml Cartridge Shade A2
00850194007848 - VistaCORE 25ml Cartridge Kit Shade A22019-12-23 VistaCORE 25ml Cartridge Kit Shade A2
00850194007855 - VistaCORE 25ml Cartridge Kit Shade White Opaque2019-12-23 VistaCORE 25ml Cartridge Kit Shade White Opaque

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.