Stern IC RN Solid Abutment 5.5mm, Biomain

GUDID 08415491062611

Intended for use with Stern IC 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 Abutment Bases which are screwed into endosseous implants.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491062611
• NIH Device Record Key: dbb35dac-448d-467f-928f-914748cfe38c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stern IC RN Solid Abutment 5.5mm, Biomain
• Version Model Number: 904702
• 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	08415491062611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111798

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08415491062611]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-06-20

On-Brand Devices [Stern IC RN Solid Abutment 5.5mm, Biomain]

• 08415491062611: Intended for use with Stern IC dental implants to support and/or retain removable dental prosthe
• 00841549113222: Intended for use with Stern IC dental implants to support and/or retain removable dental prosthe