FDA.report

COE® Adhesive

Primary DI
D6581339211
Brand
COE® Adhesive
Company
Gc America Inc.
Model
133921
Catalog number
133921
Device description
COE® ADHESIVE THINNER , 15mL
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ELWMATERIAL, IMPRESSION

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6581339211PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental impression material adhesiveA liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags

DUNS number
005473608
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D047014615Cytrans Granules10041295100412952026-03-03
D047014616Cytrans Granules10041296100412962026-03-03
D6581200012COE ALGINATE™1200011200012016-08-01
D6581200051COE ALGINATE™1200051200052016-08-01
D6581200251COE ALGINATE™1200251200252016-08-01
D6581201012COE ALGINATE™1201011201012016-08-01
D6581210012COE ALGINATE™1210011210012016-08-01
D6581211012COE ALGINATE™1211011211012016-08-01
D6581240012COE HYDROPHILIC GEL™1240011240012016-08-01
D6581241012COE HYDROPHILIC GEL™1241011241012016-08-01
D6581241251COE HYDROPHILIC GEL™1241251241252016-08-01
D6581310022COE-FLEX®1310021310022016-08-01
D6581310032COE-FLEX®1310031310032016-08-01
D6581310042COE-FLEX®1310041310042016-08-01
D6581310052COE-FLEX®1310051310052016-08-01
D6581311022COE-FLEX®1311021311022016-08-01
D6581311032COE-FLEX®1311031311032016-08-01
D6581311042COE-FLEX®1311041311042016-08-01

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E241AA6051Cavex Cream Fast Cavex Holland B.V.ELW2026-03-04
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