FDA.reportPublic FDA data

Z5m lblc

Primary DI
07640166760214
Brand
Z5m lblc
Company
Z SYSTEMS USA INCORPORATED
Model
Z5m-36-10lb
Catalog number
Z5m-36-10lb
Device description
Monotype root-form dental implant made of ZirconiaFamiliy Z5m lblcSize Z5m-36-10 lb
Published
2015-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131701000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131701000Z5MLB, Z5MLCZ-Systems AG2013-09-05DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640166760214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640166760214076401667602147640166760214

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter
Outer Diameter3.6Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(877) 874 9407usa@zsystems.com
+41623886969support@zsystems.com

Regulatory Flags#

DUNS number
033691995
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640166760122Z5mZ5m-36-08Z5m-36-082017-02-06
07640166760016Z5mZ5m-36-11Z5m-36-112015-08-25
07640166760047Z5mZ5m-40-11Z5m-40-112015-08-25
07640166760054Z5mZ5m-40-13Z5m-40-132015-08-25
07640166760085Z5mZ5m-50-10rZ5m-50-10r2015-08-25
07640166760092Z5mZ5m-50-11Z5m-50-112015-08-25
07640166760108Z5mZ5m-50-11rZ5m-50-11r2015-08-25
07640166760115Z5mZ5m-50-13Z5m-50-132015-08-25
07640166760009Z5mZ5m-36-10Z5m-36-102015-08-02
07640166760207Z5m lblcZ5m-36-08lbZ5m-36-08lb2015-08-25
07640166760221Z5m lblcZ5m-40-08lbZ5m-40-08lb2015-08-25
07640166760238Z5m lblcZ5m-40-10lbZ5m-40-10lb2015-08-25
07640166760306Z5m lblcZ5m-36-08lc-25Z5m-36-08lc-252015-08-25
07640166760313Z5m lblcZ5m-36-10lc-25Z5m-36-10lc-252015-08-25
07640166760337Z5m lblcZ5m-40-08lc-25Z5m-40-08lc252015-08-02
07640166760344Z5m lblcZ5m-40-10lc-25Z5m-40-10lc-252015-08-25
07640166760351Z5m lblcZ5m-40-12lc-25Z5m-40-12lc-252015-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532000430Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000447Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000874Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000942Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000959Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002731Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002748Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037115Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037122Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049613Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049620Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049637Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049644Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049651Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049668Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532062841Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532036965Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036972Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036989Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532049576ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532049583ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066047ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066054ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067778ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067785ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532000928ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532000935ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002649ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002656ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002663ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16