FDA.reportPublic FDA data

ZENEX MULTI Fixture

Primary DI
08800070203033
Brand
ZENEX MULTI Fixture
Company
Izenimplant Co., Ltd.
Model
ZMRM3515
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
K252585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252585000ZENEX Implant System_R-SystemIzenimplant Co., Ltd.2026-01-08DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800070203033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070203033088000702030338800070203033

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.

Regulatory Flags#

DUNS number
963328442
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
08800070202999ZENEX MULTI FixtureZMRM35082026-06-02
08800070203002ZENEX MULTI FixtureZMRM35102026-06-02
08800070203019ZENEX MULTI FixtureZMRM35112026-06-02
08800070203026ZENEX MULTI FixtureZMRM35132026-06-02
08800070203040ZENEX MULTI FixtureZMRR40072026-06-02
08800070203057ZENEX MULTI FixtureZMRR40082026-06-02
08800070203064ZENEX MULTI FixtureZMRR40102026-06-02
08800070203071ZENEX MULTI FixtureZMRR40112026-06-02
08800070203088ZENEX MULTI FixtureZMRR40132026-06-02
08800070203095ZENEX MULTI FixtureZMRR40152026-06-02
08800070203101ZENEX MULTI FixtureZMRR45072026-06-02
08800070203118ZENEX MULTI FixtureZMRR45082026-06-02
08800070203125ZENEX MULTI FixtureZMRR45102026-06-02
08800070203132ZENEX MULTI FixtureZMRR45112026-06-02
08800070203149ZENEX MULTI FixtureZMRR45132026-06-02
08800070203163ZENEX MULTI FixtureZMRR45152026-06-02
08800070203170ZENEX MULTI FixtureZMRW50072026-06-02
08800070203187ZENEX MULTI FixtureZMRW50082026-06-02
08800070203194ZENEX MULTI FixtureZMRW50102026-06-02
08800070203200ZENEX MULTI FixtureZMRW50112026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070202999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28