PUR Prosthetic Screw 0.048 Hex

GUDID 08415491155627

PUR Prosthetic Screw 0.048 Hex. PUR Prosthetic Screws are intended for fixation of abutment to dental implant. They are made from titanium 6AL-4V ELI material.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID08415491155627
NIH Device Record Key96e7eac7-60c4-414e-9202-e6f70b8b0398
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUR Prosthetic Screw 0.048 Hex
Version Model Number904768
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
GS108415491155627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491155627]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-03-06

On-Brand Devices [PUR Prosthetic Screw 0.048 Hex]

08415491155627PUR Prosthetic Screw 0.048 Hex. PUR Prosthetic Screws are intended for fixation of abutment to
00841549113505PUR Prosthetic Screw 0.048 Hex. PUR Prosthetic Screws are intended for fixation of abutment to

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