ERA® Implant Abutment Standard 0°, 3mm Cuff (BF)

GUDID 00841549103124

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 ID00841549103124
NIH Device Record Keyc7adf530-4825-4917-9a99-b208fb0f9f0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameERA® Implant Abutment Standard 0°, 3mm Cuff (BF)
Version Model Number812231
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
GS100841549103124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841549103124]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-08
Device Publish Date2017-03-16

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

08415491151780Implant retained overdentures are an established treatment modality. ERA abutments provide a res
00841549103124Implant retained overdentures are an established treatment modality. ERA abutments provide a res

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.