TRU RP Implant 6.0x10mm, Ti

GUDID 00841549107375

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. They provide for non-rotational single and multiple 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 Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID00841549107375
NIH Device Record Key428eca58-03e3-46e1-9005-0523917933b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRU RP Implant 6.0x10mm, Ti
Version Model Number901353
Company DUNS124763728
Company NameSTERNGOLD DENTAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549107375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-10
Device Publish Date2015-11-04

On-Brand Devices [TRU RP Implant 6.0x10mm, Ti]

08415491153043The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured
00841549107375The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured
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