Ormco™ EtchFree Bonding

GUDID 00889989088892

ORMCO ETCHFREE ADHESIVE, SYRINGE REFILL

ORMCO CORPORATION

Orthodontic bracket adhesive
Primary Device ID00889989088892
NIH Device Record Key517e7703-b4cb-40cd-a80d-e70e08e93c2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrmco™ EtchFree Bonding
Version Model Number740-0510
Company DUNS154614119
Company NameORMCO 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

Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com
Phone+18008541741
Emailormcocustcare@ormco.com

Device Dimensions

Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram
Weight4 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100889989088892 [Primary]

FDA Product Code

DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-19
Device Publish Date2025-05-09

On-Brand Devices [Ormco™ EtchFree Bonding]

10889989088912ORMCO ETCHFREE BONDING PRIMER, REPOSITION VIALS REFILL
00889989088908ORMCO ETCHFREE BONDING STARTER KIT
00889989088892ORMCO ETCHFREE ADHESIVE, SYRINGE REFILL
10889989088882ORMCO ETCHFREE BONDING PRIMER, SINGLE PATIENT VIALS REFILL

Trademark Results [Ormco]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORMCO
ORMCO
72197753 0805280 Live/Registered
ORMCO CORPORATION
1964-07-13

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