FDA.report

Denture Retention Attachment

Primary DI
D157DRAC352
Brand
Denture Retention Attachment
Company
BLUE ELEPHANT INC.
Model
DRA Conical 3.5 x 2mm
Catalog number
DRAC352
Published
2025-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D157DRAC352PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
099822326
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D157LNRBB01Denture Retention Attachment Housing LinerBaby Blue Liner 01LNRBB012025-05-13
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07290120481039IH Straight Shoulder Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120481237IH Straight Shoulder Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120481435IH Straight Shoulder Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482470IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482524IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482579IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482623IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482678IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486621NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486676NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486720NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486775NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486829NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486928RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486973RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487024RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487079RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487383NP Straight Anatomic Abutment 3.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487437RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487482RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487529IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487536NP Straight Anatomic Abutment 3.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487628IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487727IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487826IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120488328IH Straight Anatomic Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120488427IH Straight Anatomic Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120488526IH Straight Anatomic Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120488625IH Straight Anatomic Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24