Twist Drill (Non-stopper)

GUDID 08800070237052

Izenimplant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800070237052
NIH Device Record Keyc9273941-23f5-47f5-8439-8641ee431bdf
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwist Drill (Non-stopper)
Version Model NumberTDN3F25L
Company DUNS694625347
Company NameIzenimplant Co., Ltd.
Device Count1
DM Exemptfalse
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800070237052 [Primary]

FDA Product Code

DZADrill, Dental, Intraoral

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


[08800070237052]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-07
Device Publish Date2025-06-27

On-Brand Devices [Twist Drill (Non-stopper)]

08800070235096TDN3F46S
08800070235089TDN3F36S
08800070235072TDN3F27S
08800070235034TDN3F46L
08800070235027TDN3F36L
08800070235010TDN3F27L
08800070234976TDN3F41S
08800070234969TDN3F30S
08800070234952TDN2F22S
08800070234907TDN3F41L
08800070234891TDN3F30L
08800070234884TDN2F22L
08800070237069TDN3F25S
08800070237052TDN3F25L

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.