TRU Straight Abutment RP 3.0mm cuff - Titanium

GUDID 00841549110177

TRU Straight Abutment RP 3.0mm cuff - Titanium. TRU Standard Abutments attached directly to the implant and provide the transitional link between the head of the implant and the restorative components. They are designed to be used for screw retained multi-implant prostheses.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00841549110177
NIH Device Record Key90f2b8da-2e2e-461b-849e-b5d391cf0e8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRU Straight Abutment RP 3.0mm cuff - Titanium
Version Model Number904008
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549110177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841549110177]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-08
Device Publish Date2017-03-02

On-Brand Devices [TRU Straight Abutment RP 3.0mm cuff - Titanium]

08415491154446TRU Straight Abutment RP 3.0mm cuff - Titanium. TRU Standard Abutments attach directly to the i
00841549110177TRU Straight Abutment RP 3.0mm cuff - Titanium. TRU Standard Abutments attached directly to the

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