Z5m Z5m-36-10

GUDID 07640166769491

Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-10

Z-Systems AG

Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece
Primary Device ID07640166769491
NIH Device Record Keyf035e627-7968-4689-91da-7c3d59c51835
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ5m
Version Model NumberZ5m-36-10
Catalog NumberZ5m-36-10
Company DUNS483189556
Company NameZ-Systems AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com
Phone+41623886969
Emailsupport@zsystems.com

Device Dimensions

Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter
Outer Diameter3.6 Millimeter
Length10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107640166769491 [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 Number6
Public Version Date2024-04-19
Device Publish Date2015-08-02

Devices Manufactured by Z-Systems AG

07640166769491 - Z5m2024-04-19Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-10
07640166769491 - Z5m2024-04-19 Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-10
07640166760870 - BL-OSC-H2024-04-15 Ceramic Basal Screw, incl. single-use screwdriver
07640166764700 - BL-OST-H2024-04-15 Titanium basal screw, including single-use screwdriver
07640166760863 - BL-OST2024-04-12 Basal Screw
07640166761747 - Z5_m_c_mt leer2024-04-12 Surgical Tray Z5_m_c_mt_empty
07640166761754 - Z5_m_c_mt Inlay2024-04-12 Surgical Inlay Z5_m_c_mt
07640166761761 - Z5_Tray_Box2024-04-12 Surgical Box
07640166761778 - Z5_m_c_mt Tray FULL2024-04-12 Surgical Tray Z5_m_c_mt full
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