Harvard Bond SE Dual

GUDID EHAR177351

Self-etching dual-curing adhesive (two component system)

Harvard Dental International GmbH

Dentine bonding agent/set
Primary Device IDEHAR177351
NIH Device Record Keyd4cac578-1131-44d7-a2ec-22378c13ca8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarvard Bond SE Dual
Version Model Number17735
Company DUNS341553293
Company NameHarvard Dental International GmbH
Device Count2
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
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCC17735M [Unit of Use]
HIBCCEHAR177351 [Primary]

FDA Product Code

KLEAgent, Tooth Bonding, 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 Date2016-09-15

On-Brand Devices [Harvard Bond SE Dual]

EHAR70836051Self-etching dual-curing adhesive (two component system)
EHAR70836021Self-etching dual-curing adhesive (two component system)
EHAR177351Self-etching dual-curing adhesive (two component system)

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