FDA.reportPublic FDA data

Denture Retention Attachment Housing Liner

Primary DI
D157LNRBB01
Brand
Denture Retention Attachment Housing Liner
Company
BLUE ELEPHANT INC.
Model
Baby Blue Liner 01
Catalog number
LNRBB01
Published
2025-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D157LNRBB01PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
099822326
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D157LNRBB04Denture Retention Attachment Housing LinerBaby Blue Liner 04LNRBB042025-05-13
D157LNRBB10Denture Retention Attachment Housing LinerBaby Blue Liner 10LNRBB102025-05-13
D157LNRBL01Denture Retention Attachment Housing LinerBlack Liner 01LNRBL012025-05-13
D157LNRBL04Denture Retention Attachment Housing LinerBlack Liner 04LNRBL042025-05-13
D157LNRBL10Denture Retention Attachment Housing LinerBlack Liner 10LNRBL102025-05-13
D157LNRBR01Denture Retention Attachment Housing LinerBrown Liner 01LNRBR012025-05-13
D157LNRBR04Denture Retention Attachment Housing LinerBrown Liner 04LNRBR042025-05-13
D157LNRBR10Denture Retention Attachment Housing LinerBrown Liner 10LNRBR102025-05-13
D157LNRLI01Denture Retention Attachment Housing LinerLime Liner 01LNRLI012025-05-13
D157LNRLI04Denture Retention Attachment Housing LinerLime Liner 04LNRLI042025-05-13
D157LNRLI10Denture Retention Attachment Housing LinerLime Liner 10LNRLI102025-05-13
D157LNRVT04Denture Retention Attachment Housing LinerViolet Liner 04LNRVT042025-05-13
D157LNRVT10Denture Retention Attachment Housing LinerViolet Liner 10LNRVT102025-05-13
D157LNRWH01Denture Retention Attachment Housing LinerWhite Liner 01LNRWH012025-05-13
D157LNRWH04Denture Retention Attachment Housing LinerWhite Liner 04LNRWH042025-05-13
D157LNRWH10Denture Retention Attachment Housing LinerWhite Liner 10LNRWH102025-05-13
D157LNRYL01Denture Retention Attachment Housing LinerYellow Liner 01LNRYL012025-05-13
D157LNRYL04Denture Retention Attachment Housing LinerYellow Liner 04LNRYL042025-05-13
D157LNRYL10Denture Retention Attachment Housing LinerYellow Liner 10LNRYL102025-05-13
D157LNTVT01Denture Retention Attachment Housing LinerViolet Liner 01LNRVT012025-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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EMKA20503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA02821ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA10502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA20502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA40502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8509ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851517ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851530ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8515TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS81PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS82PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS83PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC83ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11