Bone Spreader

GUDID 08800341412416

ARUM DENTISTRY Co., Ltd.

Fixture/appliance dental drill bit, reusable
Primary Device ID08800341412416
NIH Device Record Key131215ee-23c3-4c4f-b0c5-1a1b560d5328
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Spreader
Version Model NumberBS3037
Company DUNS557821945
Company NameARUM DENTISTRY Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800341412416 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800341412416]

Moist Heat or Steam Sterilization


[08800341412416]

Moist Heat or Steam Sterilization


[08800341412416]

Moist Heat or Steam Sterilization


[08800341412416]

Moist Heat or Steam Sterilization


[08800341412416]

Moist Heat or Steam Sterilization


[08800341412416]

Moist Heat or Steam Sterilization


[08800341412416]

Moist Heat or Steam Sterilization


[08800341412416]

Moist Heat or Steam Sterilization


[08800341412416]

Moist Heat or Steam Sterilization


[08800341412416]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-04-01
Device Publish Date2026-03-24

Devices Manufactured by ARUM DENTISTRY Co., Ltd.

08800055791203 - NB Master Kit2026-04-01
08800055791210 - NB Regular Kit 2026-04-01
08800055792774 - Fixture Driver Machine2026-04-01
08800055792781 - Fixture Driver Machine2026-04-01
08800055792798 - Fixture Driver Machine2026-04-01
08800055792804 - Fixture Driver Machine2026-04-01
08800055792910 - Torque Extension2026-04-01
08800055792958 - Trial Pin2026-04-01

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.