TRU Straight Abutment RP 1.5mm cuff - Titanium

GUDID 08415491154422

TRU Straight Abutment RP 1.5mm cuff - Titanium. TRU Standard Abutments attach 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 ID08415491154422
NIH Device Record Keyaa817116-7294-4120-ab4f-276ff0bdfd64
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRU Straight Abutment RP 1.5mm cuff - Titanium
Version Model Number904005
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
GS108415491154422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491154422]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-03-02

On-Brand Devices [TRU Straight Abutment RP 1.5mm cuff - Titanium]

08415491154422TRU Straight Abutment RP 1.5mm cuff - Titanium. TRU Standard Abutments attach directly to the i
00841549110153TRU Straight Abutment RP 1.5mm cuff - Titanium. TRU Standard Abutments attach directly to the i

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