Straumann Bone Level Tapered Implant 021.5312G

GUDID 07630031730398

Bone Level Tapered Implant, Ø 4.1mm RC, SLActive® 12mm, Roxolid®, guided

Institut Straumann AG

Screw endosteal dental implant, two-piece
Primary Device ID07630031730398
NIH Device Record Key77f04bdf-08d3-40b7-ac2f-5051692ec715
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraumann Bone Level Tapered Implant
Version Model NumberSLActive Roxolid BL
Catalog Number021.5312G
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(801)448-8168
Emailinfo.usa@straumann.com

Device Dimensions

Outer Diameter4.1 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031730398 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-13
Device Publish Date2019-05-03

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