FDA.reportPublic FDA data

ZENEX Guide Fixture Driver

Primary DI
08800070231425
Brand
ZENEX Guide Fixture Driver
Company
Izenimplant Co., Ltd.
Model
ZGFDCSW25W
Published
2023-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08800070231425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070231425088000702314258800070231425

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
694625347
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03