ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (AJ)

GUDID 08415491126740

Implant retained overdentures are an established treatment modality. ERAAvailable as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant). abutments provide a resilient attachment with universal hinge movement.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID08415491126740
NIH Device Record Key5ec86912-a599-4259-a6e7-80bdb6f8e8ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameERA® Implant Abutment Micro Ang. Base, 3mm Cuff (AJ)
Version Model Number812746
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

Customer Support Contacts

Phone401-871-3489
Emailmaria.rao@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108415491126740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491126740]

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 Ang. Base, 3mm Cuff (AJ)]

08415491126740Implant retained overdentures are an established treatment modality. ERAAvailable as one piece s
00841549104251Implant retained overdentures are an established treatment modality. ERAAvailable as one piece s

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