FDA.reportPublic FDA data

ZENEX PLUS Fixture

Primary DI
08800070202739
Brand
ZENEX PLUS Fixture
Company
Izenimplant Co., Ltd.
Model
ZPTM3515
Published
2022-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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
K211090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211090000ZENEX Implant SystemIzenimplant Co., Ltd.2022-04-13DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800070202739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070202739088000702027398800070202739

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694625347
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800070229125ZENEX MULTI FixtureZMRR4515S2026-06-09
08800070229132ZENEX MULTI FixtureZMRW5007S2026-06-09
08800070229149ZENEX MULTI FixtureZMRW5008S2026-06-09
08800070229156ZENEX MULTI FixtureZMRW5010S2026-06-09
08800070229163ZENEX MULTI FixtureZMRW5011S2026-06-09
08800070229170ZENEX MULTI FixtureZMRW5013S2026-06-09
08800070229187ZENEX MULTI FixtureZMRW5015S2026-06-09
08800070229194ZENEX MULTI FixtureZMRW5507S2026-06-09
08800070229200ZENEX MULTI FixtureZMRW5508S2026-06-09
08800070229217ZENEX MULTI FixtureZMRW5510S2026-06-09
08800070229224ZENEX MULTI FixtureZMRW5511S2026-06-09
08800070229231ZENEX MULTI FixtureZMRW5513S2026-06-09
08800070229248ZENEX MULTI FixtureZMRW5515S2026-06-09
08800070229255ZENEX MULTI FixtureZMRW6007S2026-06-09
08800070229262ZENEX MULTI FixtureZMRW6008S2026-06-09
08800070229279ZENEX MULTI FixtureZMRW6010S2026-06-09
08800070229286ZENEX MULTI FixtureZMRW6011S2026-06-09
08800070229293ZENEX MULTI FixtureZMRW6013S2026-06-09
08800070229309ZENEX MULTI FixtureZMRW7007S2026-06-09
08800070229316ZENEX MULTI FixtureZMRW7008S2026-06-09

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