SURGICAL COVER SCREW SHELTA SH-VT-425-BL

GUDID D7701261383

SURGICAL COVER SCREW SHELTA D.4.25 MM

SWEDEN & MARTINA SPA

Screw endosteal dental implant, two-piece
Primary Device IDD7701261383
NIH Device Record Key41e33060-32a3-4e6b-9009-ba4626725db5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGICAL COVER SCREW SHELTA
Version Model NumberSH-VT-425-BL
Catalog NumberSH-VT-425-BL
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
HIBCCD7701261383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7701261383]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-30

On-Brand Devices [SURGICAL COVER SCREW SHELTA]

D7701261393SURGICAL COVER SCREW SHELTA D.5.00 MM
D7701261383SURGICAL COVER SCREW SHELTA D.4.25 MM
D7701261373SURGICAL COVER SCREW SHELTA D.3.80 MM
D7701064093SURGICAL COVER SCREW SHELTA D.3.80 MM

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