Stern AC Implant 4.0 x 11.5mm, Ti

GUDID 08415491150226

The Stern AC Implant is a self-tapping, double thread screw im¬plant, manufactured from pure grade 4 titanium. The implant is acid etched except for the neck, which is machined to a smooth finish. Stern AC Implants are manufactured with a flared neck, used for one-stage, transgingival implantation. The neck and body include an internal taper and octagon. The implants are manufactured with three body diameters, 3.3 mm, 4.0 mm, and 5.0 mm, all with the same prosthetic head. Intended to be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The Stern AC Dental Implant System is intended for delayed loading. It 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: 08415491150226
• NIH Device Record Key: 4643fae0-ff73-445d-9462-71ec8f4af44c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stern AC Implant 4.0 x 11.5mm, Ti
• Version Model Number: 903005
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• Device Count: 1
• DM Exempt: true
• 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	08415491150226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142667

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: 2016-10-12

On-Brand Devices [Stern AC Implant 4.0 x 11.5mm, Ti]

• 08415491150226: The Stern AC Implant is a self-tapping, double thread screw im¬plant, manufactured from pure gr
• 00841549110061: The Stern AC Implant is a self-tapping, double thread screw implant, manufactured from pure grad