Harvard Cement OptiCaps, Shade Universal

GUDID EHAR70813101

Zinc phosphate cement

Harvard Dental International GmbH

Zinc phosphate dental cement
Primary Device IDEHAR70813101
NIH Device Record Keyec03fc7c-e278-4c23-a5de-396b0bca4109
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarvard Cement OptiCaps, Shade Universal
Version Model Number7081310
Company DUNS341553293
Company NameHarvard Dental International GmbH
Device Count10
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 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCC7081310 [Unit of Use]
HIBCCEHAR70813101 [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 Date2016-09-11

On-Brand Devices [Harvard Cement OptiCaps, Shade Universal]

EHAR70813501Zinc phosphate cement
EHAR70813101Zinc phosphate cement
EHAR179431Zinc phosphate cement

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