FDA.report

COE-RECT™

Primary DI
D6583430911
Brand
COE-RECT™
Company
Gc America Inc.
Model
343091
Catalog number
343091
Device description
COE-RECT™ 6oz liquid
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
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6583430911PrimaryHIBCC0

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature21 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature70 Degrees Fahrenheit77 Degrees Fahrenheit

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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D6581200051COE ALGINATE™1200051200052016-08-01
D6581200251COE ALGINATE™1200251200252016-08-01
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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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