FDA.reportPublic FDA data

Fixture Driver Machine

Primary DI
08800055792781
Brand
Fixture Driver Machine
Company
ARUM DENTISTRY Co., Ltd.
Model
FDM31M
Published
2026-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
08800055792781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800055792781088000557927818800055792781

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
557821945
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
08800055715605Pre-milled BlankCIHE0232026-03-12
08800055715612Pre-milled BlankCIHE0242026-03-12
08800055715629Pre-milled BlankCIHE0252026-03-12
08800055715636Pre-milled BlankCIHE0262026-03-12
08800055715865Pre-milled BlankCIHE0532026-03-12
08800055715872Pre-milled BlankCIHE0542026-03-12
08800055715889Pre-milled BlankCIHE0552026-03-12
08800055715896Pre-milled BlankCIHE0562026-03-12
08800055715902Pre-milled BlankCIHE0572026-03-12
08800055715919Pre-milled BlankCIHE0582026-03-12
08800055716282Pre-milled BlankCIHE0952026-03-12
08800055716299Pre-milled BlankCIHE0962026-03-12
08800055716305Pre-milled BlankCIHE0972026-03-12
08800055716312Pre-milled BlankCIHE0982026-03-12
08800055716329Pre-milled BlankCIHE0992026-03-12
08800055716336Pre-milled BlankCIHE1002026-03-12
08800055746128Pre-milled BlankCIHE2012026-03-12
08800055746135Pre-milled BlankCIHE2022026-03-12
08800055762067Pre-milled BlankCIHE023P2026-03-12
08800055762074Pre-milled BlankCIHE024P2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07630031778437NAInstitut Straumann AGNDP2026-06-03
07630031778444NAInstitut Straumann AGNDP2026-06-03