ORA Processing Jig

GUDID 00841549116063

Implant Interface design varies, dependent upon implant type. The ORA System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants. 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

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Primary Device ID	00841549116063
NIH Device Record Key	ca34ffda-4df5-456d-b9f8-43f8eff3999e
Commercial Distribution Status	In Commercial Distribution
Brand Name	ORA Processing Jig
Version Model Number	811001
Company DUNS	124763728
Company Name	STERNGOLD DENTAL LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com
Phone	508-226-5660
Email	laura.greige@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549116063 [Primary]

FDA Product Code

NDP	Accessories, Implant, Dental, Endosseous