FDA.reportPublic FDA data

Z5m

Primary DI
07640166760009
Brand
Z5m
Company
Z SYSTEMS USA INCORPORATED
Model
Z5m-36-10
Catalog number
Z5m-36-10
Device description
Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-10
Published
2015-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K120793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120793000Z-LOOK3 EVO SLMZ-Systems AG2012-12-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640166760009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640166760009076401667600097640166760009

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
+41623886969support@zsystems.com

Regulatory Flags#

DUNS number
033691995
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07640166760207Z5m lblcZ5m-36-08lbZ5m-36-08lb2015-08-25
07640166760214Z5m lblcZ5m-36-10lbZ5m-36-10lb2015-08-25
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
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08809822767892AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767908AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767922AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767946AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767953AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12