FDA.reportPublic FDA data

Lab Driver Set

Primary DI
08800070250297
Brand
Lab Driver Set
Company
Izenimplant Co., Ltd.
Model
LD4S
Published
2026-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800070250297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070250297088000702502978800070250297

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
963328442
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800070205068Multi Healing CapMHCSR482022-05-06
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
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14