FDA.reportPublic FDA data

COE-RECT™

Primary DI
D6583430011
Brand
COE-RECT™
Company
Gc America Inc.
Model
343001
Catalog number
343001
Device description
COE-RECT™ Professional Package (1 x 6oz powder, 1 x 6oz liquid, 1 x 14mL repair liquid & accessories)
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6583430011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture reliner, hardA denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature21 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature70 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14550565002269Cytrans Granules10041295100412952026-03-03
14550565002276Cytrans Granules10041296100412962026-03-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842326128095DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128101DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128118DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128125DuraflexThe Myerson Company LimitedEBI2026-05-26
00815967025917RodinPac-Dent, Inc.EBI2026-03-23
00815967029342RodinPac-Dent, Inc.EBI2026-03-23
00815967029359RodinPac-Dent, Inc.EBI2026-03-23
00815967029366RodinPac-Dent, Inc.EBI2026-03-23
00815967029373RodinPac-Dent, Inc.EBI2026-03-23
06971437942314UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942321UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942338UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942352UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942376UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942383UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942390UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942406UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942413UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942192UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942208UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942215UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942222UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942239UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942246UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942253UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942260UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942277UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942284UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942291UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942307UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04