FDA.reportPublic FDA data

ZENEX PLUS Fixture Set

Primary DI
08800070233399
Brand
ZENEX PLUS Fixture Set
Company
Izenimplant Co., Ltd.
Model
ZPTM3520S
Published
2024-11-25
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
K240560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240560000ZENEX Implant System_LongIzenimplant Co., Ltd.2024-10-30DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800070233399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070233399088000702333998800070233399

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
08800070236871Point DrillPDS3F20L2024-12-12
08800070236888Point DrillPDS3F20S2024-12-12
08800070234877Bite Impression Coping DriverBICD4018L2024-09-13
08800070234945Bite Impression Coping DriverBICD4014S2024-09-13
08800070235003Bite Impression Coping DriverBICD5018L2024-09-13
08800070235065Bite Impression Coping DriverBICD5014S2024-09-13
08800070233610Dental T-ShaperDTSD182023-12-11
08800070226933Prosthetic Lab Driver KITPLDK2022-05-20
08800070203415ZENEX PLUS FixtureZPRM35082026-06-26
08800070203422ZENEX PLUS FixtureZPRM35102026-06-26
08800070203439ZENEX PLUS FixtureZPRM35112026-06-26
08800070203446ZENEX PLUS FixtureZPRM35132026-06-26
08800070230367ZENEX MULTI FixtureZMRW5006S2026-06-26
08800070230374ZENEX MULTI FixtureZMRW5506S2026-06-26
08800070230381ZENEX MULTI FixtureZMRW6006S2026-06-26
08800070230398ZENEX MULTI FixtureZMRW7006S2026-06-26
08800070229125ZENEX MULTI FixtureZMRW5007S2026-06-26
08800070229132ZENEX MULTI FixtureZMRW5008S2026-06-26
08800070229149ZENEX MULTI FixtureZMRW5010S2026-06-26
08800070229156ZENEX MULTI FixtureZMRW5011S2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26