MODIFICATION TO ITI DENTAL IMPLANT SYSTEM 043.942S

GUDID 07630031719768

Standard Plus Implant, D 4.8mm RN, SLA® 12mm, Ti, Loxim™

Institut Straumann AG

Screw endosteal dental implant, two-piece
Primary Device ID07630031719768
NIH Device Record Keyc28426b1-2fc0-400c-8743-566e6c23896b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMODIFICATION TO ITI DENTAL IMPLANT SYSTEM
Version Model Number1
Catalog Number043.942S
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 Datetrue
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

Length12 Millimeter
Outer Diameter4.8 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031719768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [MODIFICATION TO ITI DENTAL IMPLANT SYSTEM]

07630031719850Standard Plus Implant, D 4.8mm WN, SLA® 12mm, Ti, Loxim™
07630031719843Standard Plus Implant, D 4.8mm WN, SLA® 10mm, Ti, Loxim™
07630031719836Standard Plus Implant, D 4.8mm WN, SLA® 8mm, Ti, Loxim™
07630031719829Standard Plus Implant, D 4.8mm WN, SLA® 6mm, Ti, Loxim™
07630031719782Standard Implant, D 4.8mm WN, SLA® 6mm, Ti, Loxim™
07630031719775Standard Plus Implant, D 4.8mm RN, SLA® 14mm, Ti, Loxim™
07630031719768Standard Plus Implant, D 4.8mm RN, SLA® 12mm, Ti, Loxim™
07630031719751Standard Plus Implant, D 4.8mm RN, SLA® 10mm, Ti, Loxim™
07630031719744Standard Plus Implant, D 4.8mm RN, SLA® 8mm, Ti, Loxim™
07630031719737Standard Plus Implant, D 4.8mm RN, SLA® 6mm, Ti, Loxim™
07630031719683Standard Implant, D 4.8mm RN, SLA® 6mm, Ti, Loxim™
07630031719638Standard Plus Implant, D 4.1mm RN, SLA® 14mm, Ti, Loxim™
07630031719621Standard Plus Implant, D 4.1mm RN, SLA® 12mm, Ti, Loxim™
07630031719614Standard Plus Implant, D 4.1mm RN, SLA® 10mm, Ti, Loxim™
07630031719607Standard Plus Implant, D 4.1mm RN, SLA® 8mm, Ti, Loxim™
07630031719591Standard Plus Implant, D 4.1mm RN, SLA® 6mm, Ti, Loxim™
07630031719539Standard Implant, D 4.1mm RN, SLA® 6mm, Ti, Loxim™
07630031719485Standard Plus Implant, D 3.3mm RN, SLA® 14mm, Ti, Loxim™
07630031719478Standard Plus Implant, D 3.3mm RN, SLA® 12mm, Ti, Loxim™
07630031719461Standard Plus Implant, D 3.3mm RN, SLA® 10mm, Ti, Loxim™
07630031719454Standard Plus Implant, D 3.3mm RN, SLA® 8mm, Ti, Loxim™
07630031719201Standard Plus Implant, D 4.8mm, WN, SLA 12mm, Ti
07630031719195Standard Plus Implant, D 4.8mm, WN, SLA 10mm, Ti
07630031719188Standard Plus Implant, D 4.8mm, WN, SLA 8mm, Ti
07630031719171Standard Plus Implant, D 4.8mm, WN, SLA 6mm, Ti
07630031719133Standard Implant, D 4.8mm, WN, SLA 6mm, Ti
07630031718877Standard Plus Implant, D 4.8mm, RN, SLA 6mm, Ti
07630031718822Standard Implant, D 4.8mm, RN, SLA 6mm, Ti
07630031718372Standard Plus Implant, D 4.1mm, RN, SLA 6mm, Ti
07630031718310Standard Implant, D 4.1mm, RN, SLA 6mm, Ti
07630031701022Standard Plus Implant,D 4.8mm, RN, SLA 14mm, Ti
07630031701015Standard Plus Implant, D 4.8mm, RN, SLA 12mm, Ti
07630031701008Standard Plus Implant, D 4.8mm, RN, SLA 10mm, Ti
07630031700995Standard Plus Implant, D 4.8mm, RN, SLA 8mm, Ti
07630031700988Standard Plus Implant,D 3.3mm, RN, SLA 14mm, Ti
07630031700971Standard Plus Implant, D 3.3mm, RN, SLA 12mm, Ti
07630031700964Standard Plus Implant, D 3.3mm, RN, SLA 10mm, Ti
07630031700957Standard Plus Implant, D 3.3mm, RN, SLA 8mm, Ti
07630031700940Standard Plus Implant, D 4.1mm, RN, SLA 14mm, Ti
07630031700933Standard Plus Implant, D 4.1mm, RN, SLA 12mm, Ti
07630031700926Standard Plus Implant, D 4.1mm, RN, SLA 10mm, Ti
07630031700919Standard Plus Implant, D 4.1mm, RN, SLA 8mm, Ti

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