OUTLINK2 IMPLANT ZIRTI E2-ZT-330-100

GUDID D77010645637

OUTLINK2 IMPLANT ZIRTI D.3.30 H.10 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece
Primary Device IDD77010645637
NIH Device Record Key40edfb2e-17a4-42c3-a932-0a6d4828f08d
Commercial Distribution Discontinuation2015-10-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOUTLINK2 IMPLANT ZIRTI
Version Model NumberE2-ZT-330-100
Catalog NumberE2-ZT-330-100
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
HIBCCD77010645637 [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 Date2015-10-13

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