FDA.report

ZENEX Guide Twist Drill

Primary DI
08800070232248
Brand
ZENEX Guide Twist Drill
Company
Izenimplant Co., Ltd.
Model
ZGTD5507W
Published
2023-05-30
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

Related Records

Product Codes

CodeName
DZADrill, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800070232248PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
694625347
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800070237007Taper Cortical DrillTACD4FF552025-06-27
08800070237052Twist Drill (Non-stopper)TDN3F25L2025-06-27
08800070237069Twist Drill (Non-stopper)TDN3F25S2025-06-27
08800070236932Taper DrillTAD3F55062025-06-25
08800070236949Taper DrillTAD3F55072025-06-25
08800070236956Taper DrillTAD3F55082025-06-25
08800070236963Taper DrillTAD3F55102025-06-25
08800070236970Taper DrillTAD3F55112025-06-25
08800070236987Taper DrillTAD3F55132025-06-25
08800070236994Taper DrillTAD3F55152025-06-25
08800070237014Tap DrillTD4FF352025-06-25
08800070237021Tap DrillTD4FF402025-06-25
08800070237038Tap DrillTD4FF452025-06-25
08800070237045Tap DrillTD4FF502025-06-25
08800070237076ZENEX Direct KitZENDTSKIT2025-06-25
08800070237083ZENEX Direct KitZENDTTKIT2025-06-25
08800070237090ZENEX Direct KitZENDTRKIT2025-06-25
08800070237113Twist DrillTDM2F22L2025-06-25
08800070237120Twist DrillTDM2F25L2025-06-25
08800070237137Twist DrillTDM2F27L2025-06-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800341415158First DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415165Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415172Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415189Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415196Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415202Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415219Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415226Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415233Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415240Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415257Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415264Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
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08800055792163Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792170Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
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08800055792262Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792279Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792286Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792293Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792309Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792316Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792323Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20