Stern IC Acid Etched Implant 3.3mm RN, 1.8mm, 8mm, Biomain, Ti

GUDID 08415491062635

The Stern IC Dental Implant device is a root-form dental implant with a screw-type body, acid etched except for the neck of the implant, which is machined to a smooth finish. It is manufactured from pure grade 4 titanium with a flared neck, used for one-stage, transgingival or subgingival implantation. The neck and body include an internal taper and octagon. The implants are composed of grade 4 commercially pure titanium and are available in a range of lengths and diameters. It is intended for long term surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient’s chewing function. The Stern IC Dental Implant System is also indicated for immediate loading with good primary stability and appropriate occlusal loading.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491062635
• NIH Device Record Key: 42cd3e4d-1788-4ee3-9169-45638c35aaa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stern IC Acid Etched Implant 3.3mm RN, 1.8mm, 8mm, Biomain, Ti
• Version Model Number: 902711
• 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: true
• 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	08415491062635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111798

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-03-09

On-Brand Devices [Stern IC Acid Etched Implant 3.3mm RN, 1.8mm, 8mm, Biomain, Ti]

• 08415491062635: The Stern IC Dental Implant device is a root-form dental implant with a screw-type body, acid et
• 00841549109874: The Stern IC Dental Implant device is a root-form dental implant with a screw-type body, acid et