ERA® Implant Abutment Micro 0°, 3.5mm Cuff (AE)

GUDID 08415491064882

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

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID08415491064882
NIH Device Record Key6ea8ee6d-0b0e-4c63-b819-31dca2c7674c
Commercial Distribution StatusIn Commercial Distribution
Brand NameERA® Implant Abutment Micro 0°, 3.5mm Cuff (AE)
Version Model Number812978
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
GS108415491064882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491064882]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-04-03

On-Brand Devices [ERA® Implant Abutment Micro 0°, 3.5mm Cuff (AE)]

08415491064882Implant retained overdentures are an established treatment modality. ERA abutments provide a res
00841549106408Implant retained overdentures are an established treatment modality. ERA abutments provide a res

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