BIstite II DC

GUDID 04548190163113

Paste Clear

TOKUYAMA DENTAL CORPORATION

Dental composite resin
Primary Device ID04548190163113
NIH Device Record Keybaac2838-80c7-4bff-a362-16b71b49a850
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIstite II DC
Version Model Number16311
Company DUNS693552176
Company NameTOKUYAMA DENTAL CORPORATION
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

Customer Support Contacts

Phone1-877-378-3548
Emailinfo@tokuyama-us.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104548190163113 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [BIstite II DC ]

04548190163717Air Barrier
04548190163380Primer 2
04548190163373Primer 1B
04548190163366Primer 1A
04548190163137Paste Dentin
04548190163120Paste Ivory
04548190163113Paste Clear
04548190163083Kit Dentin
04548190163076Kit Ivory
04548190163069Kit Clear

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