TRU Prosthetic Screw RP .048 Hex

GUDID 08415491154606

TRU Prosthetic Screw RP .048" Hex. These Prosthetic Screws are intended for fixation of abutment to dental implant. They are made from titanium 6AL-4V ELI material.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491154606
• NIH Device Record Key: 1122f0d2-bfde-4f49-bc33-be5228f87e03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRU Prosthetic Screw RP .048 Hex
• Version Model Number: 904721
• 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	08415491154606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150968

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08415491154606]

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: 2017-03-02

On-Brand Devices [TRU Prosthetic Screw RP .048 Hex]

• 08415491154606: TRU Prosthetic Screw RP .048" Hex. These Prosthetic Screws are intended for fixation of abutmen
• 00841549113345: TRU Prosthetic Screw RP .048" Hex. These Prosthetic Screws are intended for fixation of abutmen