FDA.report

AXIOM®

Primary DI
03663394485227
Brand
AXIOM®
Company
ETABLISSEMENTS ANTHOGYR
Model
GFE30L6G50
Device description
GUID DRILL Ø2.4/3.0 L6.5 G5.0
Published
2024-01-17
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
03663394485227PrimaryGS10

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Device Sizes

TypeValueUnit
Length30.7Millimeter
Outer Diameter5.8Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
275978864
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
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

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08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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