TRU RP Implant 5.0x8mm, Ti

GUDID 08415491153005

The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and mul¬tiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491153005
• NIH Device Record Key: 7279ee67-8b03-4053-9e9e-5b9234c86c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRU RP Implant 5.0x8mm, Ti
• Version Model Number: 901348
• 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	08415491153005 [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: 2015-10-21

On-Brand Devices [TRU RP Implant 5.0x8mm, Ti]

• 08415491153005: The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured
• 00841549107337: The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured