FDA.reportPublic FDA data

GC RELINE™ II

Primary DI
D0470102561
Brand
GC RELINE™ II
Company
Gc America Inc.
Model
010256
Catalog number
010256
Device description
GC RELINE II™ Intro Kit ExtraExtraSoft contains: 1 GC RELINE II cartridge ExtraExtraSoft 55g (48mL), 1 GC RELINE II Primer for Resin 8g (10mL), 1 GC RELINE II Point for Trimming, 1 GC Reline II Wheel for Finishing, 1 GC Reline II Remover for Resin 5g (5.5mL), 6 pieces Mixing Tip II L, 3 Disposable brushes, 1 Plastic spatula
Published
2017-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153253000GC Reline IIGC America, Inc.2016-03-03EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0470102561PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture reliner, soft, professionalA denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags#

DUNS number
005473608
Device count
1
Lot or batch
true
Expiration date on label
true

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
10386040013437EXA Advanced1381121381122022-08-12
10386040013444EXA Advanced1381131381132022-08-12
10386040013451EXA Advanced1381161381162022-08-12
10386040013468EXA Advanced1381171381172022-08-12
10386040013475EXA Advanced1381181381182022-08-12
10386040013482EXA Advanced1381191381192022-08-12
10386040013871EQUIA®4520034520032022-07-13
D6581200011COE ALGINATE™1200011200012016-08-01
D6581201011COE ALGINATE™1201011201012016-08-01
D6581210011COE ALGINATE™1210011210012016-08-01
D6581211011COE ALGINATE™1211011211012016-08-01
D6581240011COE HYDROPHILIC GEL™1240011240012016-08-01
D6581241011COE HYDROPHILIC GEL™1241011241012016-08-01
D6581310021COE-FLEX®1310021310022016-08-01
D6581310031COE-FLEX®1310031310032016-08-01
D6581310041COE-FLEX®1310041310042016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
08056640078857major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-04-27
07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
EPRC66100851dima Print Denture Base 2pro3dure medical GmbHEBI2025-07-31
08435288443584IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443591IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443614IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443645IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443669IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443690IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443607IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443621IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443638IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443652IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443676IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
EPOLPMMP10090Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10100Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10110Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10120Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10130Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10140Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10150Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10160Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10170Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10180Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10190Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10200Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10210Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17