ERA® RV DE Female Ti

GUDID 08415491139290

The ERA RV DE Ti is an ERA distal extension attachment where the female part is made of Titanium primarily for welding into the end of a bar structure and is intended to be used 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 ID08415491139290
NIH Device Record Key232b03cf-5b90-4274-9c43-ef05e8b38d16
Commercial Distribution StatusIn Commercial Distribution
Brand NameERA® RV DE Female Ti
Version Model Number811608
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
GS108415491139290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491139290]

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® RV DE Female Ti]

08415491139290The ERA RV DE Ti is an ERA distal extension attachment where the female part is made of Titanium
00841549102226The ERA RV DE Ti is an ERA distal extension attachment where the female part is made of Titanium

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