Elos Prosthetic Screw

GUDID 05712821001917

The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.

Elos Medtech Pinol A/S

Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw
Primary Device ID05712821001917
NIH Device Record Keye03b1d5c-7f54-4a0b-aa46-97ce362ed335
Commercial Distribution StatusIn Commercial Distribution
Brand NameElos Prosthetic Screw
Version Model NumberAS-BRAM257POS
Company DUNS306155953
Company NameElos Medtech Pinol A/S
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105712821001917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


[05712821001917]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-08
Device Publish Date2020-03-31

On-Brand Devices [Elos Prosthetic Screw]

05712821001993The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821006592The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821006585The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821002099The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001986The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001979The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001962The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001955The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001948The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001917The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001900The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001894The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001863The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001856The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821002259The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821002242The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821002235The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821002082The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001849The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821001931The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
05712821001924The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
05712821010513The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821010506The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821010490The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821002013The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
05712821002006The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor

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