Stern EX Acid Etched Implant RP 4.0x11.5mm, Direct Delivery, Ti

GUDID 08415491054913

The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping, doublethreaded, root-form endosseous implants that will be available is a variety of sizes to suit individual usedpatient needs. Each implant is provided with a cover screw. The implants are manufactured from pure, implant-grade titanium. The external surface of the implants (excluding the top three threads, the neck and the implant head) is lightly acid etched to remove any traces of contaminants remaining from the manufacturing process, and to achieve a slightly roughened microsurface to aid in implant osseointegration. The proposed implants are compatible with standard, regular platform (4. lmm), external-hex (antirotational) abutments such as the currently marketed Sterngold-ImplaMed, Implant Innovations, and Branemark System (Nobel Biocare). A specially-designed SternTwist internal grip insertion tool will be available as an accessory to the Acid Etch Implants. Intended for implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For single tooth or multiple unit prosthesis.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491054913
• NIH Device Record Key: d4ce2cb5-4b3f-4b17-aac5-6f42cb1ba554
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stern EX Acid Etched Implant RP 4.0x11.5mm, Direct Delivery, Ti
• Version Model Number: 901648
• 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	08415491054913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023580

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: 2016-03-23

On-Brand Devices [Stern EX Acid Etched Implant RP 4.0x11.5mm, Direct Delivery, Ti]

• 08415491054913: The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping,
• 00841549108891: The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping,