Harvard Ionoresin Fill OptiCaps A2

GUDID EHAR70712501

Resin modified glass ionomer cement for restorations, light cure

Harvard Dental International GmbH

Glass ionomer dental cement
Primary Device IDEHAR70712501
NIH Device Record Key8bebe4e3-c0fc-477b-b8fd-38ca3b9db0a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarvard Ionoresin Fill OptiCaps A2
Version Model Number7071250
Company DUNS341553293
Company NameHarvard Dental International GmbH
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Phone+493099289780
Emailinfo@harvard-dental-international.de

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCC7071250 [Unit of Use]
HIBCCEHAR70712501 [Primary]

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-18

On-Brand Devices [Harvard Ionoresin Fill OptiCaps A2]

EHAR70712501Resin modified glass ionomer cement for restorations, light cure
EHAR177271Resin modified glass ionomer cement for restorations, light cure

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