ERA® Implant Abutment Micro 0°, 3mm Cuff (AJ)

GUDID 08415491126788

Implant retained overdentures are an established treatment modality. ERA abutments provide a resilient attachment with universal hinge movement.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID08415491126788
NIH Device Record Keyee2aef3b-7e70-4f6e-9fb4-e22ba61c0df3
Commercial Distribution StatusIn Commercial Distribution
Brand NameERA® Implant Abutment Micro 0°, 3mm Cuff (AJ)
Version Model Number812751
Company DUNS124763728
Company NameSTERNGOLD DENTAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108415491126788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491126788]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-03-23

On-Brand Devices [ERA® Implant Abutment Micro 0°, 3mm Cuff (AJ)]

08415491126788Implant retained overdentures are an established treatment modality. ERA abutments provide a res
00841549104305Implant retained overdentures are an established treatment modality. ERA abutments provide a res

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