ESTECEM II

GUDID 04548190161683

PASTE CLEAR

TOKUYAMA DENTAL CORPORATION

Dental composite resin
Primary Device ID04548190161683
NIH Device Record Keyab9427c6-426f-418a-8f88-d45e4e24c321
Commercial Distribution StatusIn Commercial Distribution
Brand NameESTECEM II
Version Model Number16168
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
GS104548190161683 [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 Date2018-09-03
Device Publish Date2018-08-01

On-Brand Devices [ESTECEM II]

04548190161881PASTE WHITE OPAQUE
04548190161782PASTE BROWN
04548190161683PASTE CLEAR
04548190161584PASTE UNIVERSAL
04548190161485KIT UNIVERSAL

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