FDA.reportPublic FDA data

ZENEX PLUS Fixture

Primary DI
08800070203415
Brand
ZENEX PLUS Fixture
Company
Izenimplant Co., Ltd.
Model
ZPRM3508
Published
2026-06-26
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
08800070203415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070203415088000702034158800070203415

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
08800070250297Lab Driver SetLD4S2026-08-07
08800070230008ZENEX PLUS FixtureZPRM3510S2026-07-29
08800070201619ZENEX MULTI FixtureZMSR45202026-07-27
08800070218600ZENEX MULTI FixtureZMTR4520S2026-07-27
08800070218891ZENEX MULTI FixtureZMTR45202026-07-27
08800070223673Free Milling AbutmentFMARRH405092026-07-27
08800070223710Free Milling AbutmentFMARRH505082026-07-27
08800070223758Free Milling AbutmentFMARRH605082026-07-27
08800070223796Free Milling AbutmentFMARRH705082026-07-27
08800070224236Free Milling Abutment [Abutment + Screw]FMARRH40509S2026-07-27
08800070224274Free Milling Abutment [Abutment + Screw]FMARRH50508S2026-07-27
08800070224311Free Milling Abutment [Abutment + Screw]FMARRH60508S2026-07-27
08800070224359Free Milling Abutment [Abutment + Screw]FMARRH70508S2026-07-27
08800070228333ZENEX MULTI FixtureZMSR4520S2026-07-27
08800070248706Short DrillSD4F412026-07-27
08800070248713Short DrillSD4F452026-07-27
08800070248720Short DrillSD4F492026-07-27
08800070248737Short DrillSD4F532026-07-27
08800070248744Short DrillSD4F572026-07-27
08800070248751Short DrillSD4F662026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516878418SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878425SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878432SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878449SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878456SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878715SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878722SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878739SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878746SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878753SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879613SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879620SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879637SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879644SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879651SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879668SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879675SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879682SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879699SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879705SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879712SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879729SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879736SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879743SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879750SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879767SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879774SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879781SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879798SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879804SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04