FDA.reportPublic FDA data

FlexDrive® Surgical Kit

Primary DI
05397311032888
Brand
FlexDrive® Surgical Kit
Company
HADER SOLUTIONS & DISTRIBUTION LIMITED
Model
1012100
Published
2026-10-26
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
NYEFixture Mount Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYEFixture Mount KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05397311032888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05397311032888053973110328885397311032888

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
985800399
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
05397311032789Driver Hex 0.9 mm1011201-12026-10-26
05397311032796Driver Hex 1.2 mm1011202-12026-10-26
05397311032802Driver Hex 1.3 mm1011203-12026-10-26
05397311032819Angled Driver1011204-12026-10-26
05397311032826Straight Driver1011205-12026-10-26
05397311032833SCS Driver1011206-12026-10-26
05397311032840Unigrip Driver1011207-12026-10-26
05397311032857Multi-Unit Driver1011208-12026-10-26
05397311032864FlexDrive® Aluminium Tray P1011209-12026-10-26
05397311032871FlexDrive® Prosthetic Kit10122002026-10-26
05397311032895Driver BioHorizons 4.51011101-12026-10-26
05397311032901Driver BioHorizons 5.71011102-12026-10-26
05397311032918Driver Hiossen ET Mini1011103-12026-10-26
05397311032925Driver Hiossen ET Regular1011104-12026-10-26
05397311032932Driver Nobel Active NP1011105-12026-10-26
05397311032949Driver Nobel Active RP1011106-12026-10-26
05397311032956Driver Nobel Tri-Lobe RP1011107-12026-10-26
05397311032963Driver Nobel Tri-Lobe WP1011108-12026-10-26
05397311032970Driver Straumann Torcfit (RB-WB)1011109-12026-10-26
05397311032987Driver Straumann Loxim1011110-12026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05397311032871FlexDrive® Prosthetic KitHADER SOLUTIONS & DISTRIBUTION LIMITEDNYE2026-10-26
08800342307186OneArch KITOsstem Implant Co., Ltd.NYE2026-10-07
08800342307193OneArch KITOsstem Implant Co., Ltd.NYE2026-10-07
06947600330943BLT Guided KitBIO CONCEPT Co., Ltd.NYE2026-05-27
08800342290136OneArch Scan Body KITOsstem Implant Co., Ltd.NYE2026-04-02
08800342289710OneArch Scan Body KITOsstem Implant Co., Ltd.NYE2026-03-05
008500733335703DDX Tapered Drill Kit 3D DIAGNOSTIX, INC.NYE2025-09-10
008500733335633DDX Straight Drill Kit3D DIAGNOSTIX, INC.NYE2025-09-10
08800271260286122 TAPER FULL KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260293122 TAPER KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260309485 KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260316TAPER KITOsstem Implant Co., Ltd.NYE2025-09-05
06947600302094TL MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304388BL MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304395BLT MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304654BC Removal Kit,BCJJ-SBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304661BC Removal Kit,BCJJ-LBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600316350BV Removal Kit,BVJJ-LBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600316589BV MINI KitBIO CONCEPT Co., Ltd.NYE2025-03-25
08800271240516Bone Compaction KITOsstem Implant Co., Ltd.NYE2025-02-03
08800271241544Bone Compaction KITOsstem Implant Co., Ltd.NYE2025-02-03
08800271234409OneArch KITOsstem Implant Co., Ltd.NYE2025-01-03
08800271229733485 KITOsstem Implant Co., Ltd.NYE2024-12-10
08800271233976OneArch KITOsstem Implant Co., Ltd.NYE2024-12-09
06947600319948BV Standard KlTBIO CONCEPT Co., Ltd.NYE2024-11-27
08800271219987Bone Compaction KITOsstem Implant Co., Ltd.NYE2024-09-26
08800271219994Bone Compaction KITOsstem Implant Co., Ltd.NYE2024-09-26
06947600316596BV Guided Kit,BVBIO CONCEPT Co., Ltd.NYE2024-09-18
08800271225438SIMPLE KITOsstem Implant Co., Ltd.NYE2024-09-10
08800271218409Taper Ultra KITOsstem Implant Co., Ltd.NYE2024-08-20