PREMIUM SP IMPLANT ZIRTI A-ZT-500SP-150

GUDID D7700843523

PREMIUM SP IMPLANT ZIRTI D.5.00 H.15 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece
Primary Device IDD7700843523
NIH Device Record Key57b226ff-b66b-4b3c-8e56-753a085bc1ae
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREMIUM SP IMPLANT ZIRTI
Version Model NumberA-ZT-500SP-150
Catalog NumberA-ZT-500SP-150
Company DUNS433815198
Company NameSWEDEN & MARTINA SPA
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 Numbertrue
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

Phone844.862.7846
Emailinfo.us@sweden-martina.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7700843523 [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 Date2015-09-21

On-Brand Devices [PREMIUM SP IMPLANT ZIRTI]

D7700843523PREMIUM SP IMPLANT ZIRTI D.5.00 H.15 MM
D7700843513PREMIUM SP IMPLANT ZIRTI D.5.00 H.8.5 MM
D7700843503PREMIUM SP IMPLANT ZIRTI D.5.00 H.7 MM
D7700843483PREMIUM SP IMPLANT ZIRTI D.4.25 H.15 MM
D7700843473PREMIUM SP IMPLANT ZIRTI D.4.25 H.8.5 MM
D7700843463PREMIUM SP IMPLANT ZIRTI D.4,25 H.7 MM
D7700843433PREMIUM SP IMPLANT ZIRTI D.3.80 H.8.5 MM
D7700642083PREMIUM SP IMPLANT ZIRTI D.5.00 H.13 MM
D7700642073PREMIUM SP IMPLANT ZIRTI D.5.00 H.11.5 MM
D7700642063PREMIUM SP IMPLANT ZIRTI D.5.00 H.10 MM
D7700642053PREMIUM SP IMPLANT ZIRTI D.4.25 H.13 MM
D7700642043PREMIUM SP IMPLANT ZIRTI D.4.25 H.11.5 MM
D7700642033PREMIUM SP IMPLANT ZIRTI D.4.25 H.10 MM
D7700642023PREMIUM SP IMPLANT ZIRTI D.3.80 H.15 MM
D7700642013PREMIUM SP IMPLANT ZIRTI D.3.80 H.13 MM
D7700642003PREMIUM SP IMPLANT ZIRTI D.3.80 H.11.5 MM
D7700641993PREMIUM SP IMPLANT ZIRTI D.3.80 H.10 MM

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