TruGUIDE Guide Point Drill

GUDID 08800076417014

Truabutment Korea Co.,Ltd

Fixture/appliance dental drill bit, reusable
Primary Device ID08800076417014
NIH Device Record Key1db24ee5-bfc1-45cb-9103-25ec1ef02038
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruGUIDE Guide Point Drill
Version Model NumberCG2-PD22
Company DUNS694514760
Company NameTruabutment Korea 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
GS108800076417014 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800076417014]

Moist Heat or Steam Sterilization


[08800076417014]

Moist Heat or Steam Sterilization


[08800076417014]

Moist Heat or Steam Sterilization


[08800076417014]

Moist Heat or Steam Sterilization


[08800076417014]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-23
Device Publish Date2025-12-15

Devices Manufactured by Truabutment Korea Co.,Ltd

08800076416857 - Bone Profiler2025-12-23
08800076416864 - Bone Profiler2025-12-23
08800076416871 - Step Drill2025-12-23
08800076416888 - Step Drill2025-12-23
08800076416895 - Step Drill2025-12-23
08800076416901 - Step Drill2025-12-23
08800076416918 - Step Drill2025-12-23
08800076417014 - TruGUIDE Guide Point Drill2025-12-23
08800076417014 - TruGUIDE Guide Point Drill2025-12-23

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