STRAUMANN DENTAL IMPLANT SYSTEM 021.2310

GUDID 07630031706461

Bone Level Implant D 3.3mm NC, SLActive® 10mm, Roxolid® Loxim™

Institut Straumann AG

Screw endosteal dental implant, two-piece
Primary Device ID07630031706461
NIH Device Record Key77d9f015-569b-4468-9d00-a2948ba53042
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTRAUMANN DENTAL IMPLANT SYSTEM
Version Model Number1
Catalog Number021.2310
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

Length10 Millimeter
Outer Diameter3.3 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031706461 [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 [STRAUMANN DENTAL IMPLANT SYSTEM]

07630031727602Tapered Effect Implant, ø4.1mm, WN, SLActive, 14.0mm, Ti
07630031727596Tapered Effect Implant, ø4.1mm, WN, SLActive, 12.0mm, Ti
07630031727589Tapered Effect Implant, ø4.1mm, WN, SLActive, 10.0mm, Ti
07630031716613Standard Plus Implant, D 3.3mm NN SLActive® 14mm, Ti
07630031716606Standard Plus Implant, D 3.3mm NN SLActive® 12mm, Ti
07630031716590Standard Plus Implant, D 3.3mm NN SLActive® 10mm, Ti
07630031716583Standard Plus Implant D 3.3mm, NN, SLActive® 8mm, Ti
07630031716576Tapered Effect Implant D 4.1mm RN, SLActive® 14mm, Ti
07630031716569Tapered Effect Implant D 4.1mm RN, SLActive® 12mm, Ti
07630031716545Tapered Effect Implant D 4.1mm RN, SLActive® 10mm, Ti
07630031716521Tapered Effect Implant D 4.1mm RN, SLActive® 8mm, Ti
07630031716507Tapered Effect Implant, D 3.3 mm, RN, SLActive 14 mm, Roxolid
07630031716491Tapered Effect Implant, D 3.3 mm, RN, SLActive 12 mm, Roxolid
07630031716484Tapered Effect Implant, D 3.3 mm, RN, SLActive 10 mm, Roxolid
07630031716477Tapered Effect Implant, D 3.3 mm, RN, SLActive 8 mm, Roxolid
07630031716460Tapered Effect Implant D 3.3mm RN, SLActive® 14mm, Ti
07630031716453Tapered Effect Implant D 3.3mm RN, SLActive® 12mm, Ti
07630031716446Tapered Effect Implant D 3.3mm RN, SLActive® 10mm, Ti
07630031716439Tapered Effect Implant D 3.3mm RN, SLActive® 8mm, Ti
07630031716422Tapered Effect Implant D 4.8mm WN, SLActive® 14mm, Ti
07630031716415Tapered Effect Implant D 4.8mm WN, SLActive® 12mm, Ti
07630031716408Tapered Effect Implant D 4.8mm WN, SLActive® 10mm, Ti
07630031716392Standard Plus Implant D 4.8mm, WN, SLActive® 12mm, Ti
07630031716385Standard Plus Implant D 4.8mm, WN, SLActive® 10mm, Ti
07630031716378Standard Plus Implant D 4.8mm, WN, SLActive® 8mm, Ti
07630031716361Standard Plus Implant D 4.8mm, WN, SLActive® 6mm, Ti
07630031716354Standard Implant D 4.8mm, WN, SLActive® 12mm, Ti
07630031716347Standard Implant D 4.8mm, WN, SLActive® 10mm, Ti
07630031716330Standard Implant D 4.8mm, WN, SLActive® 8mm, Ti
07630031716323Standard Implant D 4.8mm, WN, SLActive® 6mm, Ti
07630031715821Tapered Effect Implant, D 3.3mm RN, SLActive® 14mm, Roxolid®, Loxim™
07630031715814Tapered Effect Implant, D 3.3mm RN, SLActive® 12mm, Roxolid®, Loxim™
07630031715807Tapered Effect Implant, D 3.3mm RN, SLActive® 10mm, Roxolid®, Loxim™
07630031715784Standard Plus Implant, D 3.3mm RN, SLActive® 14mm, Roxolid®, Loxim™
07630031715777Standard Plus Implant, D 3.3mm RN, SLActive® 12mm, Roxolid®, Loxim™
07630031715760Standard Plus Implant, D 3.3mm RN, SLActive® 10mm, Roxolid®, Loxim™
07630031715746Standard Implant, D 3.3mm RN, SLActive® 16mm, Roxolid®, Loxim™
07630031715739Standard Implant, D 3.3mm RN, SLActive® 14mm, Roxolid®, Loxim™
07630031715722Standard Implant, D 3.3mm RN, SLActive® 12mm, Roxolid®, Loxim™
07630031715715Standard Implant, D 3.3mm RN, SLActive® 10mm, Roxolid®, Loxim™
07630031715708Standard Implant, D 3.3mm RN, SLActive® 8mm, Roxolid®, Loxim™
07630031715692Standard Plus Implant, D 3.3 mm, RN, SLActive 14 mm, Roxolid
07630031715685Standard Plus Implant, D 3.3 mm, RN, SLActive 12 mm, Roxolid
07630031715661Standard Plus Implant, D 3.3 mm, RN, SLActive 10 mm, Roxolid
07630031715647Standard Plus Implant, D 3.3 mm, RN, SLActive 8 mm, Roxolid
07630031715623Standard Implant, D 3.3 mm, RN, SLActive 16 mm, Roxolid
07630031715616Standard Implant, D 3.3 mm, RN, SLActive 14 mm, Roxolid
07630031715609Standard Implant, D 3.3 mm, RN, SLActive 12 mm, Roxolid
07630031715586Standard Implant, D 3.3 mm, RN, SLActive 10 mm, Roxolid
07630031715562Standard Implant, D 3.3 mm, RN, SLActive 8 mm, Roxolid

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