ORA Implant Abutment 4.0mm Cuff (X)

GUDID 00841549111303

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

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00841549111303
• NIH Device Record Key: a728d6b8-c7f1-4cc0-b2e3-17835ed947d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORA Implant Abutment 4.0mm Cuff (X)
• Version Model Number: 904393
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 401-871-3489
• Email: maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549111303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133791

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841549111303]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-08
• Device Publish Date: 2017-02-27

On-Brand Devices [ORA Implant Abutment 4.0mm Cuff (X)]

• 08415491149626: The ORA System is indicated for use with dental implants to support and/or retain removable dent
• 00841549111303: The ORA System is indicated for use with dental implants to support and/or retain removable dent