Harvard Restore A2

GUDID EHAR70832021

Light cure universal microhybrid composite

Harvard Dental International GmbH

Dental composite resin
Primary Device IDEHAR70832021
NIH Device Record Key6271c8f0-694d-429f-af23-58e94b4f0579
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarvard Restore A2
Version Model Number7083202
Company DUNS341553293
Company NameHarvard Dental International GmbH
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

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
HIBCCEHAR70832021 [Primary]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

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 Date2016-09-02

On-Brand Devices [Harvard Restore A2]

EHAR70832021Light cure universal microhybrid composite
EHAR177621Light cure universal microhybrid composite

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