FDA.reportPublic FDA data

Implant Anchor

Primary DI
08800275825566
Brand
Implant Anchor
Company
ARUM DENTISTRY Co., Ltd.
Model
IANBM12
Published
2026-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

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
08800275825566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800275825566088002758255668800275825566

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation drilling template stabilization boltA threaded bolt with a proximal flange intended to be used with a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation), to temporarily fix the template to a dental implant, immediately following implant introduction. It is intended to pass through the guide hole of the template and screw into the implant (much like a dental abutment); the proximal flange allows the template to be secured. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
557821945
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800055791203NB Master KitMAK-SET2026-03-24
08800055791210NB Regular Kit REK-SET2026-03-24
08800055792774Fixture Driver MachineFDM25M2026-03-24
08800055792781Fixture Driver MachineFDM31M2026-03-24
08800055792798Fixture Driver MachineFDM26R2026-03-24
08800055792804Fixture Driver MachineFDM32R2026-03-24
08800055792910Torque ExtensionTE012026-03-24
08800055792958Trial PinTP55132026-03-24
08800055792965Trial PinTP60132026-03-24
08800055792972Trial PinTP65132026-03-24
08800055792996Torque RatchetTR012026-03-24
08800265644320SD Surgical KitSDSK-SET2026-03-24
08800265645501Torque RatchetTR032026-03-24
08800265645532SD Multi Driver WrenchGSMD012026-03-24
08800265646492Guide Fixture Driver MachineGFDM31R2026-03-24
08800265646515SD Multi Driver MachineGSMD032026-03-24
08800265646522Anchor Screw Driver MachineGASDM2026-03-24
08800265646560Guide Fixture Driver MachineGFDM31M2026-03-24
08800275822800ARUM Prosthetic KitAPK-SET2026-03-24
08800275825498Torx Remover ToolTRTL2026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800020802767ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802774ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802781ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802798ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802804ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802811ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802828ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802835ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802842ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802859SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802866SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802873SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802880SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802897SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802903SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802910SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802927SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802934SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802996SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803009SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803016SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803023SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803030SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803047SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803054SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803061SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803078SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803085SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020858948ABIDING MU LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020859372ABIDING COUPLE DIGITAL LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26