TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS 033.562S

GUDID 07630031715968

Standard Plus Implant, D 4.1mm RN, SLActive® 10mm, Roxolid®, Loxim™

Institut Straumann AG

Screw endosteal dental implant, two-piece
Primary Device ID07630031715968
NIH Device Record Keyd27fe3dc-224a-4a48-a95b-910d5f2ffdc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
Version Model NumberSLActive Roxolid TL
Catalog Number033.562S
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 Diameter4.1 Millimeter
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
GS107630031715968 [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 Number4
Public Version Date2019-04-04
Device Publish Date2015-09-24

On-Brand Devices [TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS]

07630031716095Standard Implant, D 4.8mm RN, SLActive® 10mm, Roxolid®, Loxim™
07630031716088Standard Implant, D 4.8mm RN, SLActive® 8mm, Roxolid®, Loxim™
07630031716071Standard Implant, D 4.8mm RN, SLActive® 6mm, Roxolid®, Loxim™
07630031716064Tapered Effect Implant, D 4.1mm RN, SLActive® 14mm, Roxolid®, Loxim™
07630031716057Tapered Effect Implant, D 4.1mm RN, SLActive® 12mm, Roxolid®, Loxim™
07630031716040Tapered Effect Implant, D 4.1 RN, SLActive® 12mm, Roxolid®, guided
07630031716033Tapered Effect Implant, D 4.1mm RN, SLActive® 10mm, Roxolid®, Loxim™
07630031716026Tapered Effect Implant, D 4.1 RN, SLActive® 10mm, Roxolid®, guided
07630031716019Tapered Effect Implant, D 4.1mm RN, SLActive® 8mm, Roxolid®, Loxim™
07630031716002Tapered Effect Implant, D 4.1 RN, SLActive® 8mm, Roxolid®, guided
07630031715999Standard Plus Implant, D 4.1mm RN, SLActive® 14mm, Roxolid®, Loxim™
07630031715982Standard Plus Implant, D 4.1mm RN, SLActive® 12mm, Roxolid®, Loxim™
07630031715975Standard Plus Implant, D 4.1 RN, SLActive® 12mm, Roxolid®, guided
07630031715968Standard Plus Implant, D 4.1mm RN, SLActive® 10mm, Roxolid®, Loxim™
07630031715951Standard Plus Implant, D 4.1 RN, SLActive® 10mm, Roxolid®, guided
07630031715937Standard Plus Implant, D 4.1 RN, SLActive® 8mm, Roxolid®, guided
07630031715913Standard Implant, D 4.1mm RN, SLActive® 16mm, Roxolid®, Loxim™
07630031715906Standard Implant, D 4.1mm RN, SLActive® 14mm, Roxolid®, Loxim™
07630031715890Standard Implant, D 4.1mm RN, SLActive® 12mm, Roxolid®, Loxim™
07630031715883Standard Implant, D 4.1 RN, SLActive® 12mm, Roxolid®, guided
07630031715876Standard Implant, D 4.1mm RN, SLActive® 10mm, Roxolid®, Loxim™
07630031715869Standard Implant, D 4.1 RN, SLActive® 10mm, Roxolid®, guided
07630031715852Standard Implant, D 4.1mm RN, SLActive® 8mm, Roxolid®, Loxim™
07630031715845Standard Implant, D 4.1 RN, SLActive® 8mm, Roxolid®, guided

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