Straumann 4 mm Short Implants 033.043S

GUDID 07630031700261

Standard Plus Implant, Ø 4.1mm RN, SLActive® 4mm, Roxolid®, Loxim™

Institut Straumann AG

Screw endosteal dental implant, two-piece
Primary Device ID07630031700261
NIH Device Record Keyfaceddbf-c6d5-4a5b-a3b5-822dddb005ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraumann 4 mm Short Implants
Version Model NumberSLActive Roxolid TL
Catalog Number033.043S
Company DUNS483599259
Company NameInstitut Straumann AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com

Device Dimensions

Outer Diameter4.1 Millimeter
Length4 Millimeter
Outer Diameter4.1 Millimeter
Length4 Millimeter
Outer Diameter4.1 Millimeter
Length4 Millimeter
Outer Diameter4.1 Millimeter
Length4 Millimeter
Outer Diameter4.1 Millimeter
Length4 Millimeter
Outer Diameter4.1 Millimeter
Length4 Millimeter
Outer Diameter4.1 Millimeter
Length4 Millimeter
Outer Diameter4.1 Millimeter
Length4 Millimeter
Outer Diameter4.1 Millimeter
Length4 Millimeter
Outer Diameter4.1 Millimeter
Length4 Millimeter
Outer Diameter4.1 Millimeter
Length4 Millimeter
Outer Diameter4.1 Millimeter
Length4 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031700261 [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 Date2021-03-05
Device Publish Date2021-02-25

On-Brand Devices [Straumann 4 mm Short Implants]

07630031714640Standard Plus Implant, Ø 4.8mm WN, SLActive® 4mm, Roxolid®, Loxim™
07630031700841Standard Plus Implant, Ø 4.8mm RN, SLActive® 4mm, Roxolid®, Loxim™
07630031700261Standard Plus Implant, Ø 4.1mm RN, SLActive® 4mm, Roxolid®, Loxim™

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.