TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16 033.624S

GUDID 07630031716316

Tapered Effect Implant, D 4.8mm WN, SLActive® 14mm, Roxolid®, Loxim™

Institut Straumann AG

Screw endosteal dental implant, two-piece
Primary Device ID07630031716316
NIH Device Record Key76041e25-95e5-4593-ab5a-e3145e4a70ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameTL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16
Version Model Number1
Catalog Number033.624S
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
Length14 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031716316 [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 [TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16]

07630031716316Tapered Effect Implant, D 4.8mm WN, SLActive® 14mm, Roxolid®, Loxim™
07630031716309Tapered Effect Implant, D 4.8mm WN, SLActive® 12mm, Roxolid®, Loxim™
07630031716293Tapered Effect Implant, D 4.8mm WN, SLActive® 10mm, Roxolid®, Loxim™
07630031716279Standard Plus Implant, D 4.8mm WN, SLActive® 12mm, Roxolid®, Loxim™
07630031716262Standard Plus Implant, D 4.8mm WN, SLActive® 10mm, Roxolid®, Loxim™
07630031716255Standard Plus Implant, D 4.8mm WN, SLActive® 8mm, Roxolid®, Loxim™
07630031716248Standard Plus Implant, D 4.8mm WN, SLActive® 6mm, Roxolid®, Loxim™
07630031716231Standard Implant, D 4.8mm WN, SLActive® 12mm, Roxolid®, Loxim™
07630031716224Standard Implant, D 4.8mm WN, SLActive® 10mm, Roxolid®, Loxim™
07630031716217Standard Implant, D 4.8mm WN, SLActive® 8mm, Roxolid®, Loxim™
07630031716200Standard Implant, D 4.8mm WN, SLActive® 6mm, Roxolid®, Loxim™
07630031716194Standard Plus Implant, D 4.8mm RN, SLActive® 14mm, Roxolid®, Loxim™
07630031716187Standard Plus Implant, D 4.8mm RN, SLActive® 12mm, Roxolid®, Loxim™
07630031716170Standard Plus Implant, D 4.8 RN, SLActive® 12mm, Roxolid®, guided
07630031716163Standard Plus Implant, D 4.8mm RN, SLActive® 10mm, Roxolid®, Loxim™
07630031716156Standard Plus Implant, D 4.8 RN, SLActive® 10mm, Roxolid®, guided
07630031716132Standard Plus Implant, D 4.8 RN, SLActive® 8mm, Roxolid®, guided
07630031716118Standard Implant, D 4.8mm RN, SLActive® 14mm, Roxolid®, Loxim™
07630031716101Standard Implant, D 4.8mm RN, SLActive® 12mm, Roxolid®, Loxim™
07630031715838Standard Implant, D 4.1mm RN, SLActive® 6mm, Roxolid®, Loxim™
07630031700902Standard Plus Implant, D 4.8mm RN, SLActive® 8mm, Roxolid®, Loxim™
07630031700896Standard Plus Implant, D 4.8mm RN, SLActive® 6mm, Roxolid®, Loxim™
07630031700889Standard Plus Implant, D 4.1mm RN, SLActive® 8mm, Roxolid®, Loxim™
07630031700872Standard Plus Implant, D 4.1mm RN, SLActive® 6mm, Roxolid®, Loxim™

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