STRAUMANN ORTHOSYSTEM 048.078

GUDID 07630031722706

Cap with transpalatal arch, palatal implant, D 4.8mm, H 5.5mm, stainless steel

Institut Straumann AG

Dental implant suprastructure, permanent, preformed
Primary Device ID07630031722706
NIH Device Record Key658e1198-9672-4eaa-af69-3be6266a9396
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTRAUMANN ORTHOSYSTEM
Version Model NumberPalatal-System
Catalog Number048.078
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 Diameter4.8 Millimeter
Outer Diameter4.8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031722706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OATImplant, endosseous, orthodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031722706]

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 [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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