MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS 033.252G

GUDID 07630031714930

Standard Plus Implant D 4.8mm RN, SLActive® 10mm, Ti guided

Institut Straumann AG

Screw endosteal dental implant, two-piece
Primary Device ID07630031714930
NIH Device Record Key0921ce64-a5ce-485d-b242-6cb4ce7e4199
Commercial Distribution StatusIn Commercial Distribution
Brand NameMODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS
Version Model Number1
Catalog Number033.252G
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
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com

Device Dimensions

Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 Millimeter
Outer Diameter4.8 Millimeter
Length10 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
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
GS107630031714930 [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:STRAUMANN GUIDED INSTRUMENTS]

07630031716552Tapered Effect Implant D 4.1mm RN, SLActive® 12mm, Ti guided
07630031716538Tapered Effect Implant D 4.1mm RN, SLActive® 10mm, Ti guided
07630031716514Tapered Effect Implant D 4.1mm RN, SLActive® 8mm, Ti guided
07630031715678Standard Plus Implant D 3.3mm RN, SLActive® 12mm, Roxolid® guided
07630031715654Standard Plus Implant D 3.3mm RN, SLActive® 10mm, Roxolid® guided
07630031715630Standard Plus Implant D 3.3mm RN, SLActive® 8mm, Roxolid® guided
07630031715593Standard Implant D 3.3mm RN, SLActive® 12mm, Roxolid® guided
07630031715579Standard Implant D 3.3mm RN, SLActive® 10mm, Roxolid® guided
07630031715555Standard Implant D 3.3mm RN, SLActive® 8mm, Roxolid® guided
07630031714954Standard Plus Implant D 4.8mm RN, SLActive® 12mm, Ti guided
07630031714930Standard Plus Implant D 4.8mm RN, SLActive® 10mm, Ti guided
07630031714916Standard Plus Implant D 4.8mm RN, SLActive® 8mm, Ti guided
07630031714701Standard Plus Implant D 4.1mm RN, SLActive® 12mm, Ti guided
07630031714688Standard Plus Implant D 4.1mm RN, SLActive® 10mm, Ti guided
07630031714664Standard Plus Implant D 4.1mm RN, SLActive® 8mm, Ti guided
07630031714558Standard Implant D 4.1mm, RN, SLActive® 12mm, Ti guided
07630031714534Standard Implant D 4.1mm, RN, SLActive® 10mm, Ti guided
07630031714510Standard Implant D 4.1mm RN, SLActive® 8mm, Ti guided
07630031707222Bone Level Implant, D 4.8 mm, RC, SLActive 12 mm, Ti, guided
07630031707208Bone Level Implant, D 4.8 mm, RC, SLActive 10 mm, Ti, guided
07630031707185Bone Level Implant, D 4.8 mm, RC, SLActive 8 mm, Ti, guided
07630031706812Bone Level Implant, D 4.1 mm, RC, SLActive 12 mm, Ti, guided
07630031706799Bone Level Implant, D 4.1 mm, RC, SLActive 10 mm, Ti, guided
07630031706775Bone Level Implant, D 4.1 mm, RC, SLActive 8 mm, Ti, guided
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