BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 1 021.6308G

GUDID 07630031707253

Bone Level Implant, D 4.8mm RC SLActive® 8mm, Roxolid®, guided

Institut Straumann AG

Screw endosteal dental implant, two-piece
Primary Device ID07630031707253
NIH Device Record Key0b64b72a-6f79-4e95-a834-8bebb0290b33
Commercial Distribution StatusIn Commercial Distribution
Brand NameBL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 1
Version Model Number1
Catalog Number021.6308G
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 Diameter4.8 Millimeter
Length8 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031707253 [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 [BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 1]

07630031707307Bone Level Implant D 4.8mm RC, SLActive® 14mm, Roxolid® Loxim™
07630031707291Bone Level Implant, D 4.8mm RC SLActive® 12mm, Roxolid®, guided
07630031707284Bone Level Implant D 4.8mm RC, SLActive® 12mm, Roxolid® Loxim™
07630031707277Bone Level Implant, D 4.8mm RC SLActive® 10mm, Roxolid®, guided
07630031707260Bone Level Implant D 4.8mm RC, SLActive® 10mm, Roxolid® Loxim™
07630031707253Bone Level Implant, D 4.8mm RC SLActive® 8mm, Roxolid®, guided
07630031707246Bone Level Implant D 4.8mm RC, SLActive® 8mm, Roxolid® Loxim™
07630031706898Bone Level Implant D 4.1mm RC, SLActive® 14mm, Roxolid® Loxim™
07630031706881Bone Level Implant, D 4.1mm RC SLActive® 12mm, Roxolid®, guided
07630031706874Bone Level Implant D 4.1mm RC, SLActive® 12mm, Roxolid® Loxim™
07630031706843Bone Level Implant, D 4.1mm RC SLActive® 8mm, Roxolid®, guided
07630031706836Bone Level Implant D 4.1mm RC, SLActive® 8mm, Roxolid® Loxim™

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