SHELTA IMPLANT ZIRTI WIDE SH-ZT-425SL-085

GUDID D7701044323

SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.8.5 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece
Primary Device IDD7701044323
NIH Device Record Key916fa88b-0a1d-4264-910b-176196372622
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHELTA IMPLANT ZIRTI WIDE
Version Model NumberSH-ZT-425SL-085
Catalog NumberSH-ZT-425SL-085
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
HIBCCD7701044323 [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 [SHELTA IMPLANT ZIRTI WIDE]

D7701044413SHELTA IMPLANT ZIRTI WIDE THREAD D.5.00 H.15 MM
D7701044403SHELTA IMPLANT ZIRTI WIDE THREAD D.5.00 H.13 MM
D7701044393SHELTA IMPLANT ZIRTI WIDE THREAD D.5.00 H.11.5 MM
D7701044383SHELTA IMPLANT ZIRTI WIDE THREAD D.5.00 H.10 MM
D7701044373SHELTA IMPLANT ZIRTI WIDE THREAD D.5.00 H.8.5 MM
D7701044363SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.15 MM
D7701044353SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.13 MM
D7701044343SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.11.5 MM
D7701044333SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.10 MM
D7701044323SHELTA IMPLANT ZIRTI WIDE THREAD D.4.25 H.8.5 MM
D7701044313SHELTA IMPLANT ZIRTI WIDE THREAD D.3.80 H.15 MM
D7701044293SHELTA IMPLANT ZIRTI WIDE THREAD D.3.80 H.11.5 MM
D7701044283SHELTA IMPLANT ZIRTI WIDE THREAD D.3.80 H.10 MM
D7701044273SHELTA IMPLANT ZIRTI WIDE THREAD D.3.80 H.8.5 MM

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