STRAUMANN ORTHOSYSTEM 042.335S

GUDID 07630031718167

Palatal Implant D 4.1 mm SLA 4.2 mm, Ti

Institut Straumann AG

Screw endosteal dental implant, one-piece
Primary Device ID07630031718167
NIH Device Record Keyb6db4579-c1c7-4921-ba05-8af9aa25be96
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTRAUMANN ORTHOSYSTEM
Version Model Number1
Catalog Number042.335S
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

Outer Diameter4.1 Millimeter
Length4.2 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031718167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OATImplant, endosseous, orthodontic

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 [STRAUMANN ORTHOSYSTEM]

07630031722713Healing cap, palatal implant, D 4.8mm, H 3.5mm, PEEK
07630031722706Cap with transpalatal arch, palatal implant, D 4.8mm, H 5.5mm, stainless steel
07630031722690Cap with transpalatal arch, palatal implant, D 4.8mm, H 3.5mm, stainless steel
07630031722683Cap, palatal implant, D 4.8mm, H 5.5mm, stainless steel
07630031722676Cap, palatal implant, D 4.8mm, H 3.5mm, stainless steel
07630031718174Palatal Implant D 4.8 mm SLA 4.2 mm, Ti
07630031718167Palatal Implant D 4.1 mm SLA 4.2 mm, Ti

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