ERA® Micro DE Female Ti

GUDID 08415491137463

Micro ERA distal extension attachment where the female is made of a titanium alloy and is coated using titanium nitride. Designed to be only welded to the end of a titanium bar to retain an overdenture. 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 ID08415491137463
NIH Device Record Keyf4732913-2f64-4b24-8de9-17a094e50434
Commercial Distribution StatusIn Commercial Distribution
Brand NameERA® Micro DE Female Ti
Version Model Number811607
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
GS108415491137463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491137463]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-03-13

On-Brand Devices [ERA® Micro DE Female Ti]

08415491137463Micro ERA distal extension attachment where the female is made of a titanium alloy and is coated
00841549102219Micro ERA distal extension attachment where the female is made of a titanium alloy and is coated

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