ORA for SFI

GUDID 00841549110313

The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. Connection and retention may also be provided by a plastic keeper that is processed into the denture.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00841549110313
NIH Device Record Key6cdc7dec-37c1-40b2-a553-7c6c5a82966e
Commercial Distribution Discontinuation2017-08-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameORA for SFI
Version Model Number904063
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
GS100841549110313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841549110313]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-05-22
Device Publish Date2017-02-24

On-Brand Devices [ORA for SFI]

08415491150271The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a com
00841549110313The ORA Implant Abutment System is a precision machined ball shaped abutment that connects a com

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