T CONNECT FOR SINGLE A-TCS-425L-C

GUDID D7701112163

T CONNECT FOR SINGLE -2 CROWN FOR A/K425 CONE LARGE

SWEDEN & MARTINA SPA

Dental implant suprastructure, permanent, preformed
Primary Device IDD7701112163
NIH Device Record Keye1802183-6a69-4d61-8a05-c9624a0b25ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameT CONNECT FOR SINGLE
Version Model NumberA-TCS-425L-C
Catalog NumberA-TCS-425L-C
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
HIBCCD7701112163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7701112163]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-08-25

On-Brand Devices [T CONNECT FOR SINGLE]

D7701112173T CONNECT FOR SINGLE -2 CROWN FOR A/K500 CONE LARGE
D7701112163T CONNECT FOR SINGLE -2 CROWN FOR A/K425 CONE LARGE
D7701112143T CONNECT FOR SINGLE -2 CROWN FOR A/K380 CONE SMALL
D7701112133T CONNECT FOR SINGLE -2 CROWN FOR A 330 CONE SMALL
D7701452923T CONNECT FOR SINGLE CROWN D.3.80, TMG.H.2.5 MM
D7701452913T CONNECT FOR SINGLE CROWN D.3.80, TMG.H.1.5 MM
D7701452903T CONNECT FOR SINGLE CROWN D.3.30, TMG.H.2.5 MM
D7701452893T CONNECT FOR SINGLE CROWN D.3.30, TMG.H.1.5 MM
D7701377673T CONNECT FOR SINGLE CROWN-2, DEEP 0.5 D.5.00 LARGE
D7701377663T CONNECT FOR SINGLE CROWN-2, DEEP 0.5 D.4.25 LARGE
D7701377653T CONNECT FOR SINGLE CROWN-2, DEEP 0.5 D.3.80 SMALL

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