FDA.report

AXIOM®

Primary DI
03663394482769
Brand
AXIOM®
Company
ETABLISSEMENTS ANTHOGYR
Model
INKITSCWBL
Device description
BL M1.6 BROKEN SCREW KIT
Published
2023-12-20
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
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03663394482769PrimaryGS10

GMDN Terms

TermDefinition
Screw extractor, reusableA hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
275978864
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DIBrandModelCatalogPublished
03663394482325HAND-PIECES / CONTRE-ANGLES47562025-12-17
03663394865371HAND-PIECES / CONTRE-ANGLES1600911-0012025-08-20
03663394170871IMPULSION87M2025-02-13
03663394482332Anthogyr OSTEOTOMEINMODOSTSV2024-07-17
03663394011099TORQCONTROL155012024-03-28
03663394173346Anthogyr UNIVERSAL SURGICAL INSTRUMENTINUSI2024-02-27
03663394482936AXIOM®INBW100XL2024-01-23
03663394484275AXIOM®OPFPSL20-ET2024-01-19
03663394484282AXIOM®OPGS20-ET2024-01-19
03663394484299AXIOM®OPGS36-ET2024-01-19
03663394484305AXIOM®OPGS42-ET2024-01-19
03663394484312AXIOM®OPGS50-ET2024-01-19
03663394484329AXIOM®OPFP20-ET2024-01-19
03663394165532AXIOM®OPFPSL20-52024-01-17
03663394165549AXIOM®OPFP202024-01-17
03663394479288AXIOM®INSETIGM2024-01-17
03663394479295AXIOM®OPFPD202024-01-17
03663394479301AXIOM®OPFPSL20-32024-01-17
03663394479318AXIOM®OPGS202024-01-17
03663394479325AXIOM®OPGS20-42024-01-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800055791203NB Master KitARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800076423688URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423695URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423701URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
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