Drill Stopper

GUDID 08800070237182

Izenimplant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800070237182
NIH Device Record Key0e8d2e85-2bd3-4d57-8088-8f95e2a1609d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrill Stopper
Version Model NumberTDDSM13B
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
GS108800070237182 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800070237182]

Moist Heat or Steam Sterilization


[08800070237182]

Moist Heat or Steam Sterilization


[08800070237182]

Moist Heat or Steam Sterilization


[08800070237182]

Moist Heat or Steam Sterilization


[08800070237182]

Moist Heat or Steam Sterilization


[08800070237182]

Moist Heat or Steam Sterilization


[08800070237182]

Moist Heat or Steam Sterilization


[08800070237182]

Moist Heat or Steam Sterilization


[08800070237182]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-03
Device Publish Date2025-06-25

On-Brand Devices [Drill Stopper]

08800070226261TDDS15P
08800070226254TDDS13B
08800070226247TDDS11G
08800070226230TDDS10Y
08800070226223TDDS08P
08800070226216TDDS07B
08800070226209TDDS06G
08800070226193TDDS05Y
08800070226186TDDS04P
08800070226179TDDS03B
08800070237199TDDSM15P
08800070237182TDDSM13B
08800070237175TDDSM11G
08800070237168TDDSM10Y
08800070237151TDDSM08P

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