Bone Pen Drill

GUDID 08800036261244

Biotem Co., ltd

Dental implant system
Primary Device ID08800036261244
NIH Device Record Key7d6ecf22-2b9b-444c-a627-9997398802a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Pen Drill
Version Model NumberBPAD02M
Company DUNS557793214
Company NameBiotem Co., ltd
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800036261244 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


[08800036261244]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-26
Device Publish Date2025-08-18

On-Brand Devices [Bone Pen Drill]

08800036261244BPAD02M
08800036261237BPAD02S

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