PREMIUM ONE IMPLANT ZIRTI AS-ZT-500-115

GUDID D7701304793

PREMIUM ONE IMPLANT ZIRTI D.5.00 H.11.5 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece
Primary Device IDD7701304793
NIH Device Record Keycf414b5a-d075-435d-8d92-12e1ffc5b6f6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREMIUM ONE IMPLANT ZIRTI
Version Model NumberAS-ZT-500-115
Catalog NumberAS-ZT-500-115
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
HIBCCD7701304793 [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 Date2018-02-15

On-Brand Devices [PREMIUM ONE IMPLANT ZIRTI]

D7701304813PREMIUM ONE IMPLANT ZIRTI D.5.00 H.15 MM
D7701304803PREMIUM ONE IMPLANT ZIRTI D.5.00 H.13 MM
D7701304793PREMIUM ONE IMPLANT ZIRTI D.5.00 H.11.5 MM
D7701304783PREMIUM ONE IMPLANT ZIRTI D.5.00 H.10 MM
D7701304773PREMIUM ONE IMPLANT ZIRTI D.5.00 H.8.5 MM
D7701304763PREMIUM ONE IMPLANT ZIRTI D.5.00 H.7 MM
D7701304683PREMIUM ONE IMPLANT ZIRTI D.4.25 H.18 MM
D7701304673PREMIUM ONE IMPLANT ZIRTI D.4.25 H.15 MM
D7701304663PREMIUM ONE IMPLANT ZIRTI D.4.25 H.13 MM
D7701304653PREMIUM ONE IMPLANT ZIRTI D.4.25 H.11.5 MM
D7701304643PREMIUM ONE IMPLANT ZIRTI D.4.25 H.10 MM
D7701304633PREMIUM ONE IMPLANT ZIRTI D.4.25 H.8.5 MM
D7701304623PREMIUM ONE IMPLANT ZIRTI D.4.25 H.7 MM

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