Z5m lblc Z5m-36-08lc-25

GUDID 07640166760306

Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-36-08lc-25

Z SYSTEMS USA INCORPORATED

Screw endosteal dental implant, one-piece
Primary Device ID07640166760306
NIH Device Record Keyb9ea3015-8496-4ebf-9119-a3413c0a6e2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ5m lblc
Version Model NumberZ5m-36-08lc-25
Catalog NumberZ5m-36-08lc-25
Company DUNS033691995
Company NameZ SYSTEMS USA INCORPORATED
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(877) 874 9407
Emailusa@zsystems.com

Device Dimensions

Length8 Millimeter
Outer Diameter3.6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107640166760306 [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 Number4
Public Version Date2018-07-06
Device Publish Date2015-08-25

On-Brand Devices [Z5m lblc]

07640166760351Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-40-12lc-25
07640166760344Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-40-10 lc-25
07640166760337Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-40-08lc-25
07640166760313Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-36-10lc-25
07640166760306Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-36-08lc-25
07640166760238Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-40-10 lb
07640166760221Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-40-08 lb
07640166760214Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-36-10 lb
07640166760207Monotype root-form dental implant made of Zirconia Familiy Z5m lblc Size Z5m-36-08 lb

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