TRU NP Cover Screw 5.0mm, Ti

GUDID 08415491152916

Component that is attached to implant to protect hex, mating surface area and internal threads of implants. A cover screw closes off the inside threads of a dental implant during the period of bone healing and implant integration. Healed gingival tissue covers the cover screw and implant. Available as an Internal Hex Cover Screw and on Regular and Narrow Platforms.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491152916
• NIH Device Record Key: 42757bc8-d305-4e14-8792-fdc6c329dbef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRU NP Cover Screw 5.0mm, Ti
• Version Model Number: 901374
• 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	08415491152916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150968

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: 2016-03-02

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