ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM 048.561

GUDID 07630031725028

WN synOcta® Meso Abutment, for crown, D 10mm, Ti

Institut Straumann AG

Dental implant suprastructure, permanent, preformed
Primary Device ID07630031725028
NIH Device Record Key7c09ed8f-8111-4a2e-a258-0e2cc962308f
Commercial Distribution StatusIn Commercial Distribution
Brand NameESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
Version Model NumberFinal Abutments
Catalog Number048.561
Company DUNS483599259
Company NameInstitut Straumann AG
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)448-8168
Emailinfo.usa@straumann.com

Device Dimensions

Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031725028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031725028]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-09-24

On-Brand Devices [ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM]

07630031725028WN synOcta® Meso Abutment, for crown, D 10mm, Ti
07630031725011RN synOcta® Meso Abutment, for crown, D 8mm, Ti

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