P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS 027.4620

GUDID 07630031713766

RC Straumann® CARES® Abutment, set Ti / TAN

Institut Straumann AG

Dental implant suprastructure, permanent, preformed
Primary Device ID07630031713766
NIH Device Record Key31830417-e890-4261-bab7-f41911001b10
Commercial Distribution StatusIn Commercial Distribution
Brand NameP.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
Version Model NumberFinal Abutments
Catalog Number027.4620
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 Batchfalse
Serial Numbertrue
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 Identifiers

Device Issuing AgencyDevice ID
GS107630031713766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031713766]

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 [P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS]

07630031713773RC Straumann® CARES® Abutment, set ZrO2 / TAN
07630031713766RC Straumann® CARES® Abutment, set Ti / TAN
07630031712608RC Basal Screw, for Ceramic Abutment only, TAN

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